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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 K022483
Device Name ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING
Applicant
Johnson & Johnson Medical, Ltd.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Applicant Contact PATRICIA FLOOD
Correspondent
Johnson & Johnson Medical, Ltd.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact PATRICIA FLOOD
Classification Product Code
FRO  
Date Received07/29/2002
Decision Date 02/03/2003
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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