FDA 510(k) Application Details - K022035

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K022035
Device Name	Plate, Bone
Applicant	OSTEOMEDICS, INC. 809 CARTER LN. PARAMUS, NJ 07652 US Other 510(k) Applications for this Company
Contact	ALBERT ENYATI Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	JEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2002
Decision Date	01/17/2003
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