Surgical Mask

Mask, Surgical

Customfab, INC.

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

Pre-market Notification Details

Device IDK203012
510k NumberK203012
Device Name:Surgical Mask
ClassificationMask, Surgical
Applicant Customfab, INC. 7345 Orangewood Ave Garden Grove,  CA  92841
ContactErentia Gillmer
CorrespondentLaura Nygard
Lean RAQA, LLCX 12602 N Summer Wind Drive Marana,  AZ  85658
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-01
Decision Date2021-04-11

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