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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
Recalls CDRH Recalls
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