BARRIER LASER 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 Laser Plus Face Mask.

Pre-market Notification Details

Device IDK934194
510k NumberK934194
Device Name:BARRIER LASER PLUS FACE MASK
ClassificationMask, Surgical
Applicant JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington,  TX  76004 -3130
ContactDarrell Thompson
CorrespondentDarrell Thompson
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 Received1993-08-26
Decision Date1994-03-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07323190000760 K934194 000
07323190000524 K934194 000
07333350620141 K934194 000
07333350794071 K934194 000

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