FDA 510(k) Application Details - K991965

Device Classification Name	Accessories, Solution, Ultrasonic Cleaners For Lenses   More FDA Info for this Device
510(K) Number	K991965
Device Name	Accessories, Solution, Ultrasonic Cleaners For Lenses
Applicant	PURILENS, INC. 12300 TWINBROOK PKWY. SUITE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	RICHARD E LIPPMAN Other 510(k) Applications for this Contact
Regulation Number	886.5928   More FDA Info for this Regulation Number
Classification Product Code	LYL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/1999
Decision Date	10/01/1999
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