FDA 510(k) Application Details - K981063

Device Classification Name	Engine, Trephine, Accessories, Ac-Powered   More FDA Info for this Device
510(K) Number	K981063
Device Name	Engine, Trephine, Accessories, Ac-Powered
Applicant	LASER CENTER DEV. CORP. 1028 S. KIRKWOOD RD. SUITE A ST. LOUIS, MO 63122-7222 US Other 510(k) Applications for this Company
Contact	FRANCIS E O'DONNELL, JR. Other 510(k) Applications for this Contact
Regulation Number	886.4070   More FDA Info for this Regulation Number
Classification Product Code	HRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/1998
Decision Date	06/23/1998
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