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FDA 510(k) Application Details - K130342
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K130342
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
SAUFLON PHARMACEUTICALS, LTD.
49-53 YORK ST.
TWICKENHAM, MIDDLESEX TW1-3LP GB
Other 510(k) Applications for this Company
Contact
CHRISTOPHER SMEJKAL
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
02/11/2013
Decision Date
08/05/2013
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
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