MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS

Mask, Surgical

TECNOL NEW JERSEY WOUND CARE, INC.

The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Modification Tecnol Fluidshield Surgical Masks.

Pre-market Notification Details

Device IDK913043
510k NumberK913043
Device Name:MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS
ClassificationMask, Surgical
Applicant TECNOL NEW JERSEY WOUND CARE, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth,  TX  76180
ContactRuth L Jones
CorrespondentRuth L Jones
TECNOL NEW JERSEY WOUND CARE, 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 Received1991-06-20
Decision Date1991-08-23

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