FDA 510(k) Application Details - K983766

Device Classification Name	Mesh, Metal   More FDA Info for this Device
510(K) Number	K983766
Device Name	Mesh, Metal
Applicant	SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	JAMES MCCRACKEN Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	EZX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/1998
Decision Date	12/18/1998
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