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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 K880660
Device Name SURGITEK SUPER DOUBLE J URETERAL STENT KIT
Applicant
Surgitek
3037 Mt. Pleasant St.
Racine,  WI  53404
Applicant Contact WAXBERG
Correspondent
Surgitek
3037 Mt. Pleasant St.
Racine,  WI  53404
Correspondent Contact WAXBERG
Regulation Number876.4620
Classification Product Code
FAD  
Date Received02/17/1988
Decision Date 04/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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