FDA 510(k) Application Details - K013646

Device Classification Name	Lens, Contact (Other Material) - Daily   More FDA Info for this Device
510(K) Number	K013646
Device Name	Lens, Contact (Other Material) - Daily
Applicant	ROSE K INTERNATIONAL LTD. 60 ST. ANDREWS TCE HAMILTON NZ Other 510(k) Applications for this Company
Contact	IAN JENNINGS Other 510(k) Applications for this Contact
Regulation Number	886.5916   More FDA Info for this Regulation Number
Classification Product Code	HQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2001
Decision Date	05/30/2002
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