VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE

Plate, Bone

HOWMEDICA LEIBINGER, INC.

The following data is part of a premarket notification filed by Howmedica Leibinger, Inc. with the FDA for Vazquez Diner Intraoral Distraction Device.

Pre-market Notification Details

Device IDK964649
510k NumberK964649
Device Name:VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE
ClassificationPlate, Bone
Applicant HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas,  TX  75244
ContactKristyn R Waski
CorrespondentKristyn R Waski
HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas,  TX  75244
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-20
Decision Date1997-01-24
Summary:summary

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