Asept Surgical Face Mask

Mask, Surgical

PFM Medical, Inc

The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Asept Surgical Face Mask.

Pre-market Notification Details

Device IDK201137
510k NumberK201137
Device Name:Asept Surgical Face Mask
ClassificationMask, Surgical
Applicant PFM Medical, Inc 1916 Palomar Oaks Way, Suite 150 Carlsbad,  CA  92008
ContactJessica Jho
CorrespondentJessica Jho
PFM Medical, Inc 1916 Palomar Oaks Way, Suite 150 Carlsbad,  CA  92008
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-28
Decision Date2020-08-19

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.