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FDA 510(k) Application Details - K131783
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K131783
Device Name
Case, Contact Lens
Applicant
VIOPTI LTD
POLAROID BLDG, VALE OF LEVEN INDUSTRIAL ESTATE
DUMBARTON G82 3PW GB
Other 510(k) Applications for this Company
Contact
EDWIN LINDSAY
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
06/17/2013
Decision Date
02/21/2014
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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