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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 K980917
Device Name ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
Applicant
Fortune Medical Instrument Corp.
3722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact KAREN U SALINAS
Correspondent
Fortune Medical Instrument Corp.
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact KAREN U SALINAS
Regulation Number876.5010
Classification Product Code
GCA  
Date Received03/11/1998
Decision Date 05/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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