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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 K013814
Device Name ABSORBENT ANTIMICROBIAL WOUND DRESSING
Applicant
Convatec, A Division of E.R. Squibb & Sons
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact DEMETRIOS KYDONIEUS
Correspondent
Convatec, A Division of E.R. Squibb & Sons
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact DEMETRIOS KYDONIEUS
Classification Product Code
FRO  
Date Received11/16/2001
Decision Date 06/21/2002
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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