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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, Skin Protectant
510(k) Number K861558
Device Name APLICARE SKIN PROTECTANT 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
NEC  
Date Received04/25/1986
Decision Date 06/04/1986
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
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