FDA 510(k) Application Details - K993591

Device Classification Name	Device, Irrigation, Ocular Surgery   More FDA Info for this Device
510(K) Number	K993591
Device Name	Device, Irrigation, Ocular Surgery
Applicant	BLADE WORKS, INC. 30001 GOLDEN LANTERN #334 LAGUNA NIGUEL, CA 92677 US Other 510(k) Applications for this Company
Contact	GARY MOCNIK Other 510(k) Applications for this Contact
Regulation Number	886.4360   More FDA Info for this Regulation Number
Classification Product Code	KYG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/1999
Decision Date	12/28/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review