FDA 510(k) Application Details - K081455

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K081455
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	RAYNER SURGICAL INC SACKVILLE ROAD HOVE, EAST SUSSEX BN3 7AN GB Other 510(k) Applications for this Company
Contact	ANDREW WELLS Other 510(k) Applications for this Contact
Regulation Number	886.4300   More FDA Info for this Regulation Number
Classification Product Code	MSS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2008
Decision Date	09/05/2008
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