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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(k) Number K060804
Device Name COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING
Applicant
COVALON TECHNOLOGIES LTD.
2033 IVERSON LANES
WAXHAW,  NC  28173
Applicant Contact JACQUES LEMMETTI
Correspondent
COVALON TECHNOLOGIES LTD.
2033 IVERSON LANES
WAXHAW,  NC  28173
Correspondent Contact JACQUES LEMMETTI
Classification Product Code
FRO  
Date Received03/24/2006
Decision Date 04/18/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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