FDA 510(k) Application Details - K030027

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K030027
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	GELFLEX LABORATORIES 3 HUTTON ST., OSBORNE PARK PERTH, WESTERN, WA 6017 AU Other 510(k) Applications for this Company
Contact	PETER G BRYANT Other 510(k) Applications for this Contact
Regulation Number	886.5925   More FDA Info for this Regulation Number
Classification Product Code	LPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2003
Decision Date	04/01/2003
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