FDA 510(k) Application Details - K972081

Device Classification Name Bandage, Liquid, Skin Protectant

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510(K) Number K972081
Device Name Bandage, Liquid, Skin Protectant
Applicant MEDLOGIC GLOBAL CORP.
1300 CONNECTICUT AVE, N.W.
SUITE 1000
WASHINGTON, DC 20036 US
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Contact JUR STROBOS
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Regulation Number 880.5090

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Classification Product Code NEC
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Date Received 06/03/1997
Decision Date 12/17/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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