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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal, Long-Term Indwelling
510(k) Number K113354
Device Name VETA PERITONEAL DIALYSIS CATHETER
Applicant
Pfm Medical, Inc.
1815 Aston Ave., Suite 106
Carlsbad,  CA  92008
Applicant Contact SALVADORE PALOMARES
Correspondent
Pfm Medical, Inc.
1815 Aston Ave., Suite 106
Carlsbad,  CA  92008
Correspondent Contact SALVADORE PALOMARES
Regulation Number876.5630
Classification Product Code
FJS  
Date Received11/14/2011
Decision Date 03/13/2012
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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