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FDA 510(k) Application Details - K182616
Device Classification Name
System, Imaging, Optical Coherence Tomography (Oct)
More FDA Info for this Device
510(K) Number
K182616
Device Name
System, Imaging, Optical Coherence Tomography (Oct)
Applicant
NinePoint Medical, Inc.
12 Oak Park Drive
Bedford, MA 01730 US
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Contact
Eman Namati
Other 510(k) Applications for this Contact
Regulation Number
892.1560
More FDA Info for this Regulation Number
Classification Product Code
NQQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/21/2018
Decision Date
11/02/2018
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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