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Found 4 results
510(k) Data Aggregation
K Number
K001240Device Name
SERAGARD INJECTION PATCH
Manufacturer
PLATINUM SERVICES, INC.
Date Cleared
2000-06-21
(64 days)
Product Code
KGX
Regulation Number
880.5240Why did this record match?
Product Code :
KGX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983368Device Name
CARE BAND ANTIBACTERIAL BANDAGES
Manufacturer
ASO CORP.
Date Cleared
1999-02-17
(146 days)
Product Code
KGX
Regulation Number
880.5240Why did this record match?
Product Code :
KGX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Antibacterial bandages are to be applied topically to the skin to help prevent infoctlon in minor cuts, scrapes, and burns.
Device Description
Not Found
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K Number
K972914Device Name
SYVEK PATCH
Manufacturer
MARINE POLYMER TECHNOLOGIES, INC.
Date Cleared
1997-12-22
(137 days)
Product Code
KGX
Regulation Number
880.5240Why did this record match?
Product Code :
KGX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Syvek Patch ™ is intended for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.
Device Description
Not Found
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K Number
K943314Device Name
ADHESIVE BANDAGES WITH OTC DRUG
Manufacturer
JOHNSON & JOHNSON CONSUMER PRODUCTS, INC.
Date Cleared
1996-01-17
(555 days)
Product Code
KGX
Regulation Number
880.5240Why did this record match?
Product Code :
KGX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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