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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, Occlusive
510(k) Number K872982
Device Name JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact OMEGA NORTON-CRABLE
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact OMEGA NORTON-CRABLE
Regulation Number878.4020
Classification Product Code
NAD  
Date Received07/31/1987
Decision Date 08/14/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
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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