ISOLYSER (18X18 X-RAY DETECTABLE)

Gauze/sponge, Internal, X-ray Detectable

THANTEX SPECIALTIES, INC.

The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Isolyser (18x18 X-ray Detectable).

Pre-market Notification Details

Device IDK940762
510k NumberK940762
Device Name:ISOLYSER (18X18 X-RAY DETECTABLE)
ClassificationGauze/sponge, Internal, X-ray Detectable
Applicant THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross,  GA  30093
ContactTravis Honeycutt
CorrespondentTravis Honeycutt
THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross,  GA  30093
Product CodeGDY  
CFR Regulation Number878.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-18
Decision Date1994-05-02

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