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510(k) K190772

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR by Olympus Medical Systems Corp. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2019
Date Received
March 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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