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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 K854740
Device Name PRIMADERM
Applicant
Absorbent Cotton Co., Inc.
P.O. Box 268
368 Fairview Ave.
Hammonton,  NJ  08037
Applicant Contact PATRICK J LAMB
Correspondent
Absorbent Cotton Co., Inc.
P.O. Box 268
368 Fairview Ave.
Hammonton,  NJ  08037
Correspondent Contact PATRICK J LAMB
Regulation Number878.4020
Classification Product Code
NAD  
Date Received11/25/1985
Decision Date 03/14/1986
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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