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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 K915129
Device Name CATHETER WITH INTRODUCER AND SYRINGES
Applicant
Utah Pioneer Medical, Inc.
P.O.Box 1163
1386 W.Center St.
Orem,  UT  84057
Applicant Contact WILLIAM D.J.WALLIS
Correspondent
Utah Pioneer Medical, Inc.
P.O.Box 1163
1386 W.Center St.
Orem,  UT  84057
Correspondent Contact WILLIAM D.J.WALLIS
Regulation Number876.5010
Classification Product Code
GCA  
Date Received11/13/1991
Decision Date 04/08/1992
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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