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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 K030683
Device Name NIPRO DISPOSABLE SYRINGES
Applicant
Nipro Medical Corp.
1384 Copperfield Ct.
Lexington,  KY  40514
Applicant Contact KAELYN B HADLEY
Correspondent
Nipro Medical Corp.
1384 Copperfield Ct.
Lexington,  KY  40514
Correspondent Contact KAELYN B HADLEY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/05/2003
Decision Date 10/31/2003
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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