ASEPT PERITONEAL DRAINAGE SYSTEM

Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling

PFM MEDICAL, INC

The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Asept Peritoneal Drainage System.

Pre-market Notification Details

Device IDK093796
510k NumberK093796
Device Name:ASEPT PERITONEAL DRAINAGE SYSTEM
ClassificationPeritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Applicant PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A Oceanside,  CA  92056
ContactSalvadore Palomares
CorrespondentSalvadore Palomares
PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A Oceanside,  CA  92056
Product CodePNG  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-11
Decision Date2010-02-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10813623019109 K093796 000
10813623017068 K093796 000
10813623014227 K093796 000
10813623011158 K093796 000
20813623011117 K093796 000
20813623017041 K093796 000
04046964317330 K093796 000

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