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FDA 510(k) Application Details - K210458
Device Classification Name
System, Imaging, Optical Coherence Tomography (Oct)
More FDA Info for this Device
510(K) Number
K210458
Device Name
System, Imaging, Optical Coherence Tomography (Oct)
Applicant
Abbott Medical
4 Robbins Road
Westford, MA 01886 US
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Contact
Steve Vitale
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
02/16/2021
Decision Date
06/08/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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