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FDA 510(k) Application Details - K132800
Device Classification Name
System, Imaging, Optical Coherence Tomography (Oct)
More FDA Info for this Device
510(K) Number
K132800
Device Name
System, Imaging, Optical Coherence Tomography (Oct)
Applicant
AGFA HEALTHCARE N.V.
10 SOUTH ACADEMY STREET
GREENVILLE, SC 29601 US
Other 510(k) Applications for this Company
Contact
SHAEANN CAVANAGH
Other 510(k) Applications for this Contact
Regulation Number
892.1560
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Classification Product Code
NQQ
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More FDA Info for this Product Code
Date Received
09/06/2013
Decision Date
03/03/2014
Decision
SESE - SUBST EQUIV
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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