FDA 510(k) Application Details - K053176

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K053176
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	DUCKWORTH & KENT, LTD. 7 MARQUIS BUSINESS CENTRE ROYSTON RD. BALDOCK, HERTSFORDSHIRE SG7 6XL GB Other 510(k) Applications for this Company
Contact	MARTIN LOCK 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	11/14/2005
Decision Date	01/30/2006
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