Freudenberg Surgical Mask

Mask, Surgical

Freudenberg Performance Materials LP

The following data is part of a premarket notification filed by Freudenberg Performance Materials Lp with the FDA for Freudenberg Surgical Mask.

Pre-market Notification Details

Device IDK210063
510k NumberK210063
Device Name:Freudenberg Surgical Mask
ClassificationMask, Surgical
Applicant Freudenberg Performance Materials LP 3500 Industrial Drive Durham,  NC  27704
ContactEberhard Link
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-01-11
Decision Date2021-02-05

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