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FDA 510(k) Application Details - K171313
Device Classification Name
Microscope, Specular
More FDA Info for this Device
510(K) Number
K171313
Device Name
Microscope, Specular
Applicant
Tomey Corporation
2-11-33 Noritakeshinmachi Nishiku
Nagoya 4510051 JP
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Contact
Tomoko Watanabe
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
05/04/2017
Decision Date
01/19/2018
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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