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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
510(k) Number K913294
Device Name SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
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 Number876.5010
Classification Product Code
GCA  
Date Received07/24/1991
Decision Date 10/04/1991
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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