FACE MASK, SURGICAL MASK, NON-STERILE

Mask, Surgical

TUCKER & ASSOCIATES

The following data is part of a premarket notification filed by Tucker & Associates with the FDA for Face Mask, Surgical Mask, Non-sterile.

Pre-market Notification Details

Device IDK970835
510k NumberK970835
Device Name:FACE MASK, SURGICAL MASK, NON-STERILE
ClassificationMask, Surgical
Applicant TUCKER & ASSOCIATES 19001 SOUTH RICHFIELD, SUITE 185 Green Valley,  AZ  85614
ContactJanna P Tucker
CorrespondentJanna P Tucker
TUCKER & ASSOCIATES 19001 SOUTH RICHFIELD, SUITE 185 Green Valley,  AZ  85614
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-19
Decision Date1997-09-03

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