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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K923299
Device Name APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK
Applicant
Aplicare, Inc.
7 Orchard Park Rd.
Madison,  CT  06443
Applicant Contact PAUL G BUCCETTI
Correspondent
Aplicare, Inc.
7 Orchard Park Rd.
Madison,  CT  06443
Correspondent Contact PAUL G BUCCETTI
Regulation Number880.5090
Classification Product Code
KMF  
Date Received07/06/1992
Decision Date 01/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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