FDA 510(k) Application Details - K081382

Device Classification Name	Lens, Guide, Intraocular   More FDA Info for this Device
510(K) Number	K081382
Device Name	Lens, Guide, Intraocular
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	KYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2008
Decision Date	10/23/2008
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