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FDA 510(k) Application Details - K170470
Device Classification Name
Biomicroscope, Slit-Lamp, Ac-Powered
More FDA Info for this Device
510(K) Number
K170470
Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Applicant
Medimaging Integrated Solution Inc. (MiiS)
1F, No.7, R&D Rd. II
Hsinchu Science Park
Hsinchu 30076 TW
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Contact
Yi-Ying Chen
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
02/16/2017
Decision Date
10/06/2017
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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