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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 K102969
Device Name IMC PISTON SYRINGES
Applicant
INTERNATIONAL MEDSURG CONNECTION
935 N PLUM GROVE RD, STE F
SCHAUMBURG,  IL  60173
Applicant Contact PETER KIM
Correspondent
INTERNATIONAL MEDSURG CONNECTION
935 N PLUM GROVE RD, STE F
SCHAUMBURG,  IL  60173
Correspondent Contact PETER KIM
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received10/06/2010
Decision Date 12/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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