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 IDK920108
510k NumberK920108
Device Name:BARRIER EXTRA PROTECTION PLUS FACE MASK
ClassificationMask, Surgical
Applicant JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington,  TX  76004 -3130
ContactWendt
CorrespondentWendt
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 Received1992-01-10
Decision Date1994-02-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07323190046058 K920108 000
07333350550288 K920108 000
07323190000586 K920108 000
07323190000647 K920108 000
07323190000913 K920108 000
07323190001118 K920108 000
07323190045181 K920108 000
07323190045907 K920108 000
07323190045938 K920108 000
07323190045990 K920108 000
07333350623876 K920108 000

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