FDA 510(k) Application Details - K990064

Device Classification Name	Apparatus, Cautery, Radiofrequency, Ac-Powered   More FDA Info for this Device
510(K) Number	K990064
Device Name	Apparatus, Cautery, Radiofrequency, Ac-Powered
Applicant	OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 DOWNSVIEW, ONTARIO MEJ 3E5 CA Other 510(k) Applications for this Company
Contact	GEORGE MYERS Other 510(k) Applications for this Contact
Regulation Number	886.4100   More FDA Info for this Regulation Number
Classification Product Code	HQR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/1999
Decision Date	04/04/1999
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