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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K110882
Device Name IMC INSULIN SYRINGE
Applicant
INTERNATIONAL MEDSURG CONNECTION
935 N. PLUM GROVE ROAD,
SUITE F
SCHAUMBURG,  IL  60173
Applicant Contact PETER KIM
Correspondent
INTERNATIONAL MEDSURG CONNECTION
935 N. PLUM GROVE ROAD,
SUITE F
SCHAUMBURG,  IL  60173
Correspondent Contact PETER KIM
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/30/2011
Decision Date 08/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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