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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 K972081
Device Name SUPERSKIN
Applicant
MEDLOGIC GLOBAL CORP.
1300 CONNECTICUT AVE, N.W.
SUITE 1000
WASHINGTON,  DC  20036
Applicant Contact JUR STROBOS
Correspondent
MEDLOGIC GLOBAL CORP.
1300 CONNECTICUT AVE, N.W.
SUITE 1000
WASHINGTON,  DC  20036
Correspondent Contact JUR STROBOS
Regulation Number880.5090
Classification Product Code
NEC  
Date Received06/03/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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