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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
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