FDA 510(k) Application Details - K071203

Device Classification Name	Accessories, Soft Lens Products   More FDA Info for this Device
510(K) Number	K071203
Device Name	Accessories, Soft Lens Products
Applicant	OPTIKEM INTERNATIONAL, INC. 2214 SANFORD DRIVE UNIT B7 GRAND JUNCTION, CO 81505 US Other 510(k) Applications for this Company
Contact	MARTIN DALSING Other 510(k) Applications for this Contact
Regulation Number	886.5928   More FDA Info for this Regulation Number
Classification Product Code	LPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2007
Decision Date	06/13/2007
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