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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
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