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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 K992699
Device Name NIPRO BLOOD COLLECTION NEEDLE
Applicant
Nipro Medical Corp.
1384 Copperfield Ct.
Lexington,  KY  40514
Applicant Contact KAELYN HADLEY
Correspondent
Nipro Medical Corp.
1384 Copperfield Ct.
Lexington,  KY  40514
Correspondent Contact KAELYN HADLEY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/12/1999
Decision Date 02/14/2000
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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