FDA 510(k) Application Details - K002586

Device Classification Name	Implant, Temporal   More FDA Info for this Device
510(K) Number	K002586
Device Name	Implant, Temporal
Applicant	POREX SURGICAL PRODUCTS GROUP 15 DART RD. NEWNAN, GA 30265-1017 US Other 510(k) Applications for this Company
Contact	HOWARD MERCER Other 510(k) Applications for this Contact
Regulation Number	878.3550   More FDA Info for this Regulation Number
Classification Product Code	MNF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2000
Decision Date	11/17/2000
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