Humask Pro Vision, Humask Pro Vision 3000

Mask, Surgical

Entreprise Premont Inc.

The following data is part of a premarket notification filed by Entreprise Premont Inc. with the FDA for Humask Pro Vision, Humask Pro Vision 3000.

Pre-market Notification Details

Device IDK222551
510k NumberK222551
Device Name:Humask Pro Vision, Humask Pro Vision 3000
ClassificationMask, Surgical
Applicant Entreprise Premont Inc. 731 Boul. Saint-Laurent Est Louiseville,  CA J5V 1J1
ContactCharlie Marchand
CorrespondentCharlie Marchand
Enterprise Premont Inc. 731 Boulevard Saint-Laurent Est Louiseville,  CA J5V 1J1
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-23
Decision Date2022-11-10

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