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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 K811384
Device Name HEMASITE VASCULAR ACCESS SHUNT
Applicant
RENAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RENAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5540
Classification Product Code
FIQ  
Date Received05/19/1981
Decision Date 07/31/1981
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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