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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 K895207
Device Name BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM
Applicant
Johnson & Johnson International
410 George St.
New Brunswick,  NJ  08901
Applicant Contact OMEGA NORTON-CRABLE
Correspondent
Johnson & Johnson International
410 George St.
New Brunswick,  NJ  08901
Correspondent Contact OMEGA NORTON-CRABLE
Classification Product Code
FRO  
Date Received08/17/1989
Decision Date 09/28/1989
Decision Substantially Equivalent (SESE)
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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