TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

DAVIS & GECK, INC.

The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Tetrafluoroethylene (tfe) Polymer Pledget.

Pre-market Notification Details

Device IDK953289
510k NumberK953289
Device Name:TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
ClassificationPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant DAVIS & GECK, INC. ONE CASPER ST. Danbury,  CT  06810
ContactLynne A Newquist
CorrespondentLynne A Newquist
DAVIS & GECK, INC. ONE CASPER ST. Danbury,  CT  06810
Product CodeDXZ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-14
Decision Date1995-08-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521103174 K953289 000
20884521104645 K953289 000
20884521104638 K953289 000
20884521104614 K953289 000
20884521103181 K953289 000

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