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FDA 510(k) Application Details - K142417
Device Classification Name
Microscope, Specular
More FDA Info for this Device
510(K) Number
K142417
Device Name
Microscope, Specular
Applicant
TOPCON CORPORATION
75-1 Hasunuma-Cho, Itabashi-ku
Tokyo 174-8580 JP
Other 510(k) Applications for this Company
Contact
Michael Gusel
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
NQE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2014
Decision Date
05/29/2015
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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