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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 K051574
Device Name NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
Applicant
Nipro Medical Corp.
1384 Copperfield Court
Lexington,  KY  40514 -1268
Applicant Contact KAELYN HADLEY
Correspondent
Nipro Medical Corp.
1384 Copperfield Court
Lexington,  KY  40514 -1268
Correspondent Contact KAELYN HADLEY
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received06/14/2005
Decision Date 08/26/2005
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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