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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 K130781
Device Name L.A.M. IPM WOUND GEL, IPM DERM GEL
Applicant
Glycobiosciences, Inc.
181 Lakeshore Rd. E.
Mississauga, Ontario,  CA L5G 1G2
Applicant Contact OLUFEMI ADEOYE
Correspondent
Glycobiosciences, Inc.
181 Lakeshore Rd. E.
Mississauga, Ontario,  CA L5G 1G2
Correspondent Contact OLUFEMI ADEOYE
Classification Product Code
FRO  
Date Received03/21/2013
Decision Date 02/14/2014
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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