FDA 510(k) Application Details - K983885

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K983885
Device Name	Plate, Bone
Applicant	HOWMEDICA, INC. 359 VETERANS BLVD. RUTHERFORD, NJ 07070 US Other 510(k) Applications for this Company
Contact	JOSEPH VOLPE 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	11/02/1998
Decision Date	01/29/1999
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