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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, fistula
510(k) Number K991623
Device Name NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
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 Number876.5540
Classification Product Code
FIE  
Date Received05/11/1999
Decision Date 08/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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