DISPOSABLE FACE MASK

Mask, Oxygen

CADEMA MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Cadema Medical Products, Inc. with the FDA for Disposable Face Mask.

Pre-market Notification Details

Device IDK896773
510k NumberK896773
Device Name:DISPOSABLE FACE MASK
ClassificationMask, Oxygen
Applicant CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown,  NY  10940
ContactKathleen D Bordoni
CorrespondentKathleen D Bordoni
CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown,  NY  10940
Product CodeBYG  
CFR Regulation Number868.5580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-01
Decision Date1990-01-12

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