FDA 510(k) Application Details - K980647

Device Classification Name	Device, Irrigation, Ocular Surgery   More FDA Info for this Device
510(K) Number	K980647
Device Name	Device, Irrigation, Ocular Surgery
Applicant	EYE-DEAL OCULAR SAFETY PRODUCTS, INC. P.O. BOX 560 STILLWATER, MN 55082 US Other 510(k) Applications for this Company
Contact	ELAINE DUNCAN 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	02/17/1998
Decision Date	05/15/1998
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