AMC R METACARPAL COMPONENT

Prosthesis, Wrist, Carpal Lunate

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Amc R Metacarpal Component.

Pre-market Notification Details

Device IDK790793
510k NumberK790793
Device Name:AMC R METACARPAL COMPONENT
ClassificationProsthesis, Wrist, Carpal Lunate
Applicant HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKWN  
CFR Regulation Number888.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-24
Decision Date1979-06-22

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