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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 K955182
Device Name NIPRO ARTERIAL VENOUS FISTULA NEEDLE
Applicant
NISSHO CORP.
7205 CORPORATE CENTER DR.
# 305
MIAMI,  FL  33126
Applicant Contact LUIS CANDELARIO
Correspondent
NISSHO CORP.
7205 CORPORATE CENTER DR.
# 305
MIAMI,  FL  33126
Correspondent Contact LUIS CANDELARIO
Regulation Number876.5540
Classification Product Code
FIE  
Date Received11/13/1995
Decision Date 06/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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