LUHR MANDIBULAR/SMALL FIXATION IMPLANTS

Plate, Bone

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Luhr Mandibular/small Fixation Implants.

Pre-market Notification Details

Device IDK950595
510k NumberK950595
Device Name:LUHR MANDIBULAR/SMALL FIXATION IMPLANTS
ClassificationPlate, Bone
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactJohn Dichiara
CorrespondentJohn Dichiara
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-09
Decision Date1995-07-12

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