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FDA 510(k) Application Details - K182376
Device Classification Name
System, Image Management, Ophthalmic
More FDA Info for this Device
510(K) Number
K182376
Device Name
System, Image Management, Ophthalmic
Applicant
Topcon Medical Systems, Inc.
111 Bauer Drive
Oakland, NJ 07436 US
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Contact
James Lorkowski
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
NFJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/31/2018
Decision Date
09/28/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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