APLICARE SKIN PROTECTANT SWABSTICK

Bandage, Liquid, Skin Protectant

APLICARE, INC.

The following data is part of a premarket notification filed by Aplicare, Inc. with the FDA for Aplicare Skin Protectant Swabstick.

Pre-market Notification Details

Device IDK861558
510k NumberK861558
Device Name:APLICARE SKIN PROTECTANT SWABSTICK
ClassificationBandage, Liquid, Skin Protectant
Applicant APLICARE, INC. 7 ORCHARD PARK RD. Madison,  CT  06443
ContactPaul G Buccetti
CorrespondentPaul G Buccetti
APLICARE, INC. 7 ORCHARD PARK RD. Madison,  CT  06443
Product CodeNEC  
CFR Regulation Number880.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-25
Decision Date1986-06-04

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