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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 K892851
Device Name ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER
Applicant
Johnson & Johnson Patient Care, Inc.
New Brunswick,  NJ  08903
Applicant Contact RICHARD J SKALSKI
Correspondent
Johnson & Johnson Patient Care, Inc.
New Brunswick,  NJ  08903
Correspondent Contact RICHARD J SKALSKI
Classification Product Code
FRO  
Date Received04/18/1989
Decision Date 09/26/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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