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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 K772362
Device Name AVF SET FOR SINGLE NEEDLE HEMODIALYSIS
Applicant
TERUMO AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TERUMO AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5540
Classification Product Code
FIE  
Date Received12/27/1977
Decision Date 03/17/1978
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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