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510(k) K861558

Device
APLICARE SKIN PROTECTANT SWABSTICK
Applicant
APLICARE, INC.
510(k) number
K861558
Product code
NEC  
Decision
Substantially Equivalent (SESE)
Decision date
1986-06-04
Date received
1986-04-25
Regulation
880.5090
Classification name
Bandage, Liquid, Skin Protectant
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL G BUCCETTI
Address
7 Orchard Park Rd. Madison CT US 06443 06443

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NEC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972081SUPERSKINMedlogic Global Corp.1997-12-17
K861557APLICARE SKIN PROTECTANT PREP PADAplicare, Inc.1986-07-11

Legacy Summary#

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FDA Review#

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