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FDA 510(k) Application Details - K024003
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K024003
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
GELFLEX
THREE HUTTON ST.
OSBORNE PARK
PERTH 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
12/04/2002
Decision Date
02/05/2003
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
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