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FDA 510(k) Application Details - K130805
Device Classification Name
Products, Contact Lens Care, Rigid Gas Permeable
More FDA Info for this Device
510(K) Number
K130805
Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Applicant
MENICON CO. LTD.
187 BALLARDVALE STREET
SUITE 180
WILMINGTON, MA 01887 US
Other 510(k) Applications for this Company
Contact
Ellen M Beucler
Other 510(k) Applications for this Contact
Regulation Number
886.5918
More FDA Info for this Regulation Number
Classification Product Code
MRC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/25/2013
Decision Date
07/03/2013
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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