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FDA 510(k) Application Details - K132667
Device Classification Name
System, Image Management, Ophthalmic
More FDA Info for this Device
510(K) Number
K132667
Device Name
System, Image Management, Ophthalmic
Applicant
TOPCON MEDICAL SYSTEMS, INC.
5 TIMBER LANE
NORTH READING, MA 01864 US
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Contact
MAUREEN O'CONNELL
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
NFJ
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More FDA Info for this Product Code
Date Received
08/27/2013
Decision Date
10/09/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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