FDA 510(k) Application Details - K121315

Device Classification Name	Prosthesis, Chin, Internal   More FDA Info for this Device
510(K) Number	K121315
Device Name	Prosthesis, Chin, Internal
Applicant	HOWMEDICA OSTEONICS CORP. 15 Dart Rd NEWNAN, GA 30265 US Other 510(k) Applications for this Company
Contact	STEPHANIE FULLARD Other 510(k) Applications for this Contact
Regulation Number	878.3550   More FDA Info for this Regulation Number
Classification Product Code	FWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2012
Decision Date	11/01/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review