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510(k) Data Aggregation
K Number
K972336Device Name
DERMAMEND HYDROGEL GAUZE DRESSING
Manufacturer
Date Cleared
1997-07-29
(36 days)
Product Code
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
DERMARX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To absorb exudate and to create and maintain a moist environment for partial and full thickness wounds including pressure ulcers, stage I-V; stasis ulers; dermal wounds; 1ª and 2ª degree burns; cuts, abrasions, and other imitations of the skin.
Device Description
DermaMend™ Hydrogel Gauze Dressing
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K Number
K970600Device Name
DERMAMEND FOAM ISLAND DRESSING
Manufacturer
Date Cleared
1997-05-08
(79 days)
Product Code
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
DERMARX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K962089Device Name
DERMAMEND GEL
Manufacturer
Date Cleared
1996-11-05
(160 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DERMARX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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