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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 K913928
Device Name SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT
Applicant
Surgitek Medical Engineering Corp.
3037 Mt. Pleasant St.
Racine,  WI  53404
Applicant Contact WILLIAM H DUFFELL
Correspondent
Surgitek Medical Engineering Corp.
3037 Mt. Pleasant St.
Racine,  WI  53404
Correspondent Contact WILLIAM H DUFFELL
Regulation Number876.4620
Classification Product Code
FAD  
Date Received09/03/1991
Decision Date 11/19/1991
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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