FDA 510(k) Application Details - K083752

Device Classification Name Bandage, Liquid

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510(K) Number K083752
Device Name Bandage, Liquid
Applicant GLUSTITCH, INC.
#307 7188 PROGRESS WAY
DELTA, B.C. V4G 1M6 CA
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Contact DON BLACKLOCK
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 12/17/2008
Decision Date 02/23/2009
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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