FDA 510(k) Application Details - K002395

Device Classification Name	Tonometer, Ac-Powered   More FDA Info for this Device
510(K) Number	K002395
Device Name	Tonometer, Ac-Powered
Applicant	XOMED, INC. 6743 SOUTHPOINT DR. NORTH JACKSONVILLE, FL 32216-0980 US Other 510(k) Applications for this Company
Contact	DIANA PRESTON Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	HKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2000
Decision Date	12/11/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review