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Found 8 results
510(k) Data Aggregation
K Number
K963724Device Name
GAUZE SPONGE, NON X-RAY DETECTABLEManufacturer
Date Cleared
1996-11-29
(74 days)
Product Code
Regulation Number
N/AType
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GRAND MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K963721Device Name
SKIN SCRUB TRAYManufacturer
Date Cleared
1996-11-27
(72 days)
Product Code
Regulation Number
878.4370Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GRAND MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K963714Device Name
GRAND MEDICAL SUTURE REMOVAL KITManufacturer
Date Cleared
1996-11-27
(72 days)
Product Code
Regulation Number
878.4800Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GRAND MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K963715Device Name
DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAYManufacturer
Date Cleared
1996-11-27
(72 days)
Product Code
Regulation Number
878.4370Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GRAND MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K963719Manufacturer
Date Cleared
1996-11-27
(72 days)
Product Code
Regulation Number
880.5075Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GRAND MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K963720Device Name
TRACHEOSTOMY KITManufacturer
Date Cleared
1996-11-27
(72 days)
Product Code
Regulation Number
N/AType
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GRAND MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K963722Device Name
IV START KITManufacturer
Date Cleared
1996-11-27
(72 days)
Product Code
Regulation Number
880.5200Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GRAND MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
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K Number
K963723Device Name
LACERATION TRAYManufacturer
Date Cleared
1996-11-27
(72 days)
Product Code
Regulation Number
878.4800Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
GRAND MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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