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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 K910917
Device Name CATHLAB SILICONE BILIARY BALLOON CATHETER
Applicant
Cathlab Corp.
17991 Fitch
Irvine,  CA  92714
Applicant Contact DANIEL R LUCAS
Correspondent
Cathlab Corp.
17991 Fitch
Irvine,  CA  92714
Correspondent Contact DANIEL R LUCAS
Regulation Number876.5010
Classification Product Code
GCA  
Date Received03/05/1991
Decision Date 08/02/1991
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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