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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Subclavian
510(k) Number K914162
Device Name VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS
Applicant
Vas-Cath, Inc.
2380 Tedio St.
Mississauga,Ontario,  CA L5A3V3
Applicant Contact MARCO A.GUILLEN
Correspondent
Vas-Cath, Inc.
2380 Tedio St.
Mississauga,Ontario,  CA L5A3V3
Correspondent Contact MARCO A.GUILLEN
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received09/17/1991
Decision Date 07/01/1993
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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