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Found 119 results
510(k) Data Aggregation
K Number
K974852Device Name
NON-PRESCRIPTION SUNGLASSES
Manufacturer
CHIA HUI SPECTACLES MFG. CORP.
Date Cleared
1998-01-30
(32 days)
Product Code
HQY
Regulation Number
886.5850Why did this record match?
Product Code :
HQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
Device Description
Not Found
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K Number
K974860Device Name
NON-PRESCRIPTION SUNGLASSES
Manufacturer
WENZHOU MING MING OPTICAL CO. , LTD.
Date Cleared
1998-01-30
(32 days)
Product Code
HQY
Regulation Number
886.5850Why did this record match?
Product Code :
HQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
Device Description
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.
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K Number
K974861Device Name
NON-PRESCRIPTION SUNGLASSES
Manufacturer
WENZHOU HINDAR OPTICAL CO., LTD.
Date Cleared
1998-01-27
(29 days)
Product Code
HQY
Regulation Number
886.5850Why did this record match?
Product Code :
HQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosenstitzed lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
Device Description
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosenstitzed lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.
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K Number
K974511Device Name
SUNGLASSES
Manufacturer
SUN WORLD INTL., INC.
Date Cleared
1998-01-12
(42 days)
Product Code
HQY
Regulation Number
886.5850Why did this record match?
Product Code :
HQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
Device Description
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses.
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K Number
K974441Device Name
SUNGLASSES
Manufacturer
HIP SHING FAT CO., LTD.
Date Cleared
1998-01-09
(45 days)
Product Code
HQY
Regulation Number
886.5850Why did this record match?
Product Code :
HQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
Device Description
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.
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K Number
K973528Device Name
SUNGLASSES
Manufacturer
JEOU JEOU LONG INDUSTRIAL CO., LTD.
Date Cleared
1997-12-08
(82 days)
Product Code
HQY
Regulation Number
886.5850Why did this record match?
Product Code :
HQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
Device Description
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.
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K Number
K974414Device Name
MULTI
Manufacturer
MORNING CALM CORP.
Date Cleared
1997-12-08
(14 days)
Product Code
HQY
Regulation Number
886.5850Why did this record match?
Product Code :
HQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-prescription sunglasses are for general use to protect eyes from strong sunlight
Device Description
Not Found
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K Number
K974179Device Name
NON-PRESCRIPTION SUNGLASSES
Manufacturer
TAIPAN OPTICAL COMPANY LTD.
Date Cleared
1997-12-01
(25 days)
Product Code
HQY
Regulation Number
886.5850Why did this record match?
Product Code :
HQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
Device Description
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.
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K Number
K974045Device Name
VENNETO
Manufacturer
AMSURE SPORTS, INC.
Date Cleared
1997-11-20
(27 days)
Product Code
HQY, 86H
Regulation Number
886.5850Why did this record match?
Product Code :
HQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.
Device Description
Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.
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K Number
K973934Device Name
SUNGLASSES
Manufacturer
ELEGANCE OPTICAL MANUFACTORY, LTD.
Date Cleared
1997-11-18
(34 days)
Product Code
HQY
Regulation Number
886.5850Why did this record match?
Product Code :
HQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.
Device Description
Not Found
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