C-MASK(FLAT)

Mask, Surgical

PROMEDICA PRODUCTS, INC.

The following data is part of a premarket notification filed by Promedica Products, Inc. with the FDA for C-mask(flat).

Pre-market Notification Details

Device IDK882883
510k NumberK882883
Device Name:C-MASK(FLAT)
ClassificationMask, Surgical
Applicant PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach,  CA  92660
ContactLee Hand
CorrespondentLee Hand
PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach,  CA  92660
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-11
Decision Date1988-08-10

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