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FDA 510(k) Application Details - K142897
Device Classification Name
Ophthalmoscope,Laser,Scanning
More FDA Info for this Device
510(K) Number
K142897
Device Name
Ophthalmoscope,Laser,Scanning
Applicant
OPTOS PLC.
QUEENSFERRY HOUSE, CARNEGIE BUSINESS CAMPUS
DUNFERMLINE KY11 8GR GB
Other 510(k) Applications for this Company
Contact
GUNHILD PAULSEN
Other 510(k) Applications for this Contact
Regulation Number
886.1570
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Classification Product Code
MYC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/03/2014
Decision Date
01/16/2015
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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