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510(k) Premarket Notification Database

Device Classification Name plate, fixation, bone
510(k) NumberK961485
Device NameFOREFOOT RECONSTRUCTION SYSTEM
Applicant
HOWMEDICA CORP.
359 veterans blvd.
rutherford,  NJ  07070
Contactjohn dichiara
Regulation Number888.3030
Classification Product Code
HRS
Subsequent Product Code
JEY
Date Received04/18/1996
Decision Date 06/01/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 02/06/2009

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