FDA 510(k) Application Details - K132002

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K132002
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	RAYNER INTRAOCULAR LENSES LTD. 1-2 SACKVILLE ROAD HOVE, EAST SUSSEX BN3 7AN GB Other 510(k) Applications for this Company
Contact	JULIETTE E COOK 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	07/01/2013
Decision Date	03/27/2014
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	Y
Expedited Review