FDA 510(k) Application Details - K033656

Device Classification Name	Case, Contact Lens   More FDA Info for this Device
510(K) Number	K033656
Device Name	Case, Contact Lens
Applicant	SAUFLON PHARMACEUTICALS, LTD. 49-53 YORK ST. TWICKENHAM, MIDDLESEX TW1-3LP GB Other 510(k) Applications for this Company
Contact	LIGIA DELACRUZ Other 510(k) Applications for this Contact
Regulation Number	886.5928   More FDA Info for this Regulation Number
Classification Product Code	LRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2003
Decision Date	02/02/2004
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