FDA 510(k) Application Details - K050638

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K050638
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	LENSTEC, INC. 2870 SCHERER DR., SUITE 300 ST. PETERSBURG, FL 33716 US Other 510(k) Applications for this Company
Contact	LUIS RUIZ 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	03/11/2005
Decision Date	05/31/2005
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