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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, a-v shunt
510(k) Number K822880
Device Name ARTERIO VENOUS SHUNT CANNULA & ADAPTORS
Applicant
RENAL SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
RENAL SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5540
Classification Product Code
FIQ  
Date Received09/21/1982
Decision Date 10/18/1982
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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