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FDA 510(k) Application Details - K161764
Device Classification Name
Biomicroscope, Slit-Lamp, Ac-Powered
More FDA Info for this Device
510(K) Number
K161764
Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Applicant
CHONGQING YEASN SCIENCE-TECHNOLOGY CO., LTD
5 DANLONG ROAD
NAN'AN DISTRICT 400060 CN
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Contact
BING HU
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
06/27/2016
Decision Date
02/16/2017
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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