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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beads, Hydrophilic, For Wound Exudate Absorption
510(k) Number K896828
Device Name BIOCLUSIVE(R) ABSORBENT DRESSING
Applicant
Johnson & Johnson International
410 George St.
New Brunswick,  NJ  08901
Applicant Contact JAMES E MCCANN
Correspondent
Johnson & Johnson International
410 George St.
New Brunswick,  NJ  08901
Correspondent Contact JAMES E MCCANN
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received12/04/1989
Decision Date 11/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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