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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 K903945
Device Name EXEL A-V FISTULA SET
Original Applicant
EXEL INTL.
p.o. box 3194
culver city,  CA  90231 3194
Original Contact eshagh hamid
Regulation Number876.5540
Classification Product Code
FIE  
Date Received08/27/1990
Decision Date 11/20/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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