FDA 510(k) Application Details - K983528

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K983528
Device Name	Plate, Bone
Applicant	HOWMEDICA CORP. 359 VETERANS BLVD. RUTHERFORD, NJ 07070 US Other 510(k) Applications for this Company
Contact	VIVIAN KELLY 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	10/08/1998
Decision Date	12/23/1998
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