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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 K022159
Device Name PISTON SYRINGE & HYPODERMIC NEEDLE
Applicant
International Medsurg Connection
P.O.Box 848
Grayslake,  IL  60030
Applicant Contact MICHELE H VOVOLKA
Correspondent
International Medsurg Connection
P.O.Box 848
Grayslake,  IL  60030
Correspondent Contact MICHELE H VOVOLKA
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received07/02/2002
Decision Date 11/07/2002
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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