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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 K761093
Device Name BANDAGE
Applicant
Paco Pharmaceutical Services, Inc.
1200 Paco Way
Bldg. 19
Lakewood,  NJ  08701
Correspondent
Paco Pharmaceutical Services, Inc.
1200 Paco Way
Bldg. 19
Lakewood,  NJ  08701
Regulation Number878.4020
Classification Product Code
NAD  
Date Received11/22/1976
Decision Date 01/06/1977
Decision Substantially Equivalent (SESE)
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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