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510(k) Data Aggregation
K Number
K051273Device Name
DIVAS DUAL PLEASURE MALE LATEX CONDOM
Manufacturer
Date Cleared
2005-08-19
(94 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
EAGLE TWE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Divas Dual Pleasure condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.
Device Description
This condom is made of a natural rubber latex sheath, which closely fitted membrane. The device is shaped, teat ended, lubricated condom, which is lubricated with a water based warming lubricant. The device is designed to conform to national and international voluntary standards, including ISO 4074 and ASTM D3492, except where noted.
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K Number
K010028Device Name
SHEER THIN AROMAS RED LATEX CONDOM
Manufacturer
Date Cleared
2001-03-30
(86 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
EAGLE TWE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K004051Device Name
SHEER THIN AROMAS YELLOW LATEX CONDOM
Manufacturer
Date Cleared
2001-03-29
(90 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
EAGLE TWE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K004016Device Name
SHEER THIN AROMAS BLUE LATEX CONDOM
Manufacturer
Date Cleared
2001-03-27
(90 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
EAGLE TWE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K004036Device Name
SHEER THIN AROMAS GREEN LATEX CONDOM
Manufacturer
Date Cleared
2001-03-27
(89 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
EAGLE TWE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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