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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(k) Number K143527
Device Name IPM Wound Gel Bio, IPM Derm Gel Bio
Applicant
GLYCOBIOSCIENCES, INC
7 TIMBER COURT
GEORGETOWN,  CA L7G 4S4
Applicant Contact Kevin Drizen
Correspondent
GLYCOBIOSCIENCES, INC
7 TIMBER COURT
GEORGETOWN,  CA L7G 4S4
Correspondent Contact Kevin Drizen
Classification Product Code
FRO  
Date Received12/12/2014
Decision Date 04/20/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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