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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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