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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K102584
Device Name IMC HYPODERMIC NEEDLE
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 Number880.5570
Classification Product Code
FMI  
Date Received09/08/2010
Decision Date 01/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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