FDA 510(k) Application Details - K123193

Device Classification Name Dressing, Wound, Drug

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510(K) Number K123193
Device Name Dressing, Wound, Drug
Applicant GLYCOBIOSCIENCES, INC
7 TIMBER COURT
GERGETOWN, ONTARIO L7G 4S4 CA
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Contact KEVIN DRIZEN
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 10/11/2012
Decision Date 03/03/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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