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FDA 510(k) Application Details - K152535
Device Classification Name
Biomicroscope, Slit-Lamp, Ac-Powered
More FDA Info for this Device
510(K) Number
K152535
Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Applicant
TAKAGI SEIKO CO., LTD.
330-2 IWAHUNE, NAKANO-SHI, NAGANO-KEN
NAGANO 383-8585 JP
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Contact
Nagaike Yoshio
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
HJO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/04/2015
Decision Date
05/26/2016
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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