Savvy Mask - Level 3 Surgical Face Mask

Mask, Surgical

Texas MedPlast LLC

The following data is part of a premarket notification filed by Texas Medplast Llc with the FDA for Savvy Mask - Level 3 Surgical Face Mask.

Pre-market Notification Details

Device IDK213406
510k NumberK213406
Device Name:Savvy Mask - Level 3 Surgical Face Mask
ClassificationMask, Surgical
Applicant Texas MedPlast LLC 6630 Roxburgh Drive #171 Houston,  TX  77041
ContactDiego Olmos
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-10-19
Decision Date2021-11-18

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