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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stent, Ureteral
510(k) Number K833782
Device Name SURGITEK ALL SILICONE INFECTION DOUBJ
Applicant
SURGITEK
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SURGITEK
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.4620
Classification Product Code
FAD  
Date Received10/28/1983
Decision Date 04/02/1984
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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