TECNOL FLUIDSHIELD INFECTION CONTROL MASK

Mask, Surgical

TECNOL MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Tecnol Medical Products, Inc. with the FDA for Tecnol Fluidshield Infection Control Mask.

Pre-market Notification Details

Device IDK915817
510k NumberK915817
Device Name:TECNOL FLUIDSHIELD INFECTION CONTROL MASK
ClassificationMask, Surgical
Applicant TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth,  TX  76180
ContactRuth L Jones
CorrespondentRuth L Jones
TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth,  TX  76180
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-30
Decision Date1993-01-27

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