INTRAORAL MANDIBULAR DISTRACTION DEVICE

Plate, Bone

MEDICON, E.G.

The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Intraoral Mandibular Distraction Device.

Pre-market Notification Details

Device IDK970256
510k NumberK970256
Device Name:INTRAORAL MANDIBULAR DISTRACTION DEVICE
ClassificationPlate, Bone
Applicant MEDICON, E.G. 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
ContactHoward M Holstein, Esq.
CorrespondentHoward M Holstein, Esq.
MEDICON, E.G. 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-23
Decision Date1997-03-11

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