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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ureteral, Gastro-Urology
510(k) Number K930483
Device Name URETERAL CATHETER
Applicant
Surgitek
3037 Mt. Pleasant St.
Racine,  WI  53404
Applicant Contact BRIAN KUNST
Correspondent
Surgitek
3037 Mt. Pleasant St.
Racine,  WI  53404
Correspondent Contact BRIAN KUNST
Regulation Number876.5130
Classification Product Code
EYB  
Date Received01/29/1993
Decision Date 07/16/1993
Decision Substantially Equivalent - Kit (SESK)
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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