FDA 510(k) Application Details - K133285

Device Classification Name	Prosthesis, Condyle, Mandibular, Temporary   More FDA Info for this Device
510(K) Number	K133285
Device Name	Prosthesis, Condyle, Mandibular, Temporary
Applicant	Stryker 750 TRADE CENTRE WAY STE 200 PORTAGE, MI 49002 US Other 510(k) Applications for this Company
Contact	JAMSHED BADARPURA Other 510(k) Applications for this Contact
Regulation Number	872.3960   More FDA Info for this Regulation Number
Classification Product Code	NEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2013
Decision Date	04/09/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review