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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 K881731
Device Name AD-HEAL(TM) WOUND DRESSING
Applicant
Nepera, Inc.
Rte. 17
Harriman,  NY  10926
Applicant Contact JOSEPH R FLICEK
Correspondent
Nepera, Inc.
Rte. 17
Harriman,  NY  10926
Correspondent Contact JOSEPH R FLICEK
Regulation Number878.4020
Classification Product Code
NAD  
Date Received04/22/1988
Decision Date 08/31/1988
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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