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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name peritoneal, drainage catheter for refractory ascites, long-term indwelling
510(k) Number K093796
Device Name ASEPT PERITONEAL DRAINAGE SYSTEM
Applicant
PFM MEDICAL, INC
2605 TEMPLE HEIGHTS DRIVE
SUITE A
OCEANSIDE,  CA  92056
Applicant Contact SALVADORE PALOMARES
Correspondent
PFM MEDICAL, INC
2605 TEMPLE HEIGHTS DRIVE
SUITE A
OCEANSIDE,  CA  92056
Correspondent Contact SALVADORE PALOMARES
Regulation Number876.5630
Classification Product Code
PNG  
Date Received12/11/2009
Decision Date 02/26/2010
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
Recalls CDRH Recalls
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