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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 K911181
Device Name INTIMAX(TM) IRRIGATION CATHETER
Applicant
Applied Vascular Devices, Inc.
26051 Merit Cir., #104
Laguna Hills,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
Applied Vascular Devices, Inc.
26051 Merit Cir., #104
Laguna Hills,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number876.5010
Classification Product Code
GCA  
Date Received03/18/1991
Decision Date 04/18/1991
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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