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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 K043296
Device Name COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
Applicant
Covalontechnologies, Inc.
14510 Kandi Court
Largo,  FL  33774
Applicant Contact PAUL L GUILBAUD
Correspondent
Covalontechnologies, Inc.
14510 Kandi Court
Largo,  FL  33774
Correspondent Contact PAUL L GUILBAUD
Classification Product Code
FRO  
Date Received11/29/2004
Decision Date 06/06/2005
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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