BARRIER* EXTRA PROTECTION PLUS FACE MASK

Mask, Surgical

JOHNSON & JOHNSON MEDICAL, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Barrier* Extra Protection Plus Face Mask.

Pre-market Notification Details

Device IDK910557
510k NumberK910557
Device Name:BARRIER* EXTRA PROTECTION PLUS FACE MASK
ClassificationMask, Surgical
Applicant JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington,  TX  76004 -3130
ContactT. M Wendt
CorrespondentT. M Wendt
JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington,  TX  76004 -3130
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-08
Decision Date1991-04-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07323190043279 K910557 000

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