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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Securement Wound Dressing For Reduction Of Infection
510(k) Number K003229
Device Name BIOPATCH ANTIMICROBIAL DRESSING
Applicant
Integra Lifesciences Corp.
Rte 22
Somerville,  NJ  08876
Applicant Contact WILLIAM GOELLER
Correspondent
Integra Lifesciences Corp.
Rte 22
Somerville,  NJ  08876
Correspondent Contact WILLIAM GOELLER
Classification Product Code
SEL  
Date Received10/10/2000
Decision Date 10/26/2001
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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