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510(k) K972081

Device
SUPERSKIN
Applicant
MEDLOGIC GLOBAL CORP.
510(k) number
K972081
Product code
NEC  
Decision
Substantially Equivalent (SESE)
Decision date
1997-12-17
Date received
1997-06-03
Regulation
880.5090
Classification name
Bandage, Liquid, Skin Protectant
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JUR STROBOS
Address
1300 Connecticut Ave., NW Suite 1000 Washington DC US 20036 20036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NEC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K861557APLICARE SKIN PROTECTANT PREP PADAplicare, Inc.1986-07-11
K861558APLICARE SKIN PROTECTANT SWABSTICKAplicare, Inc.1986-06-04

Legacy Summary#

summary

FDA Review#

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