FDA 510(k) Application Details - K123113

Device Classification Name Dressing, Wound, Drug

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510(K) Number K123113
Device Name Dressing, Wound, Drug
Applicant GLYCOBIOSCIENCES, INC
181 LAKESHORE ROAD EAST
MISSISSAUGA, ONTARIO L5G 1G2 CA
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Contact JAMES JOHNSON
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 10/03/2012
Decision Date 12/11/2012
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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