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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, angiographic
510(k) Number K190772
Device Name SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho
hachioji-shi,  JP 192-8507
Applicant Contact toshiyuki nakajima
Correspondent
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
center valley,  PA  18034 -0610
Correspondent Contact sheri l. musgnung
Regulation Number892.1600
Classification Product Code
IZI  
Subsequent Product Code
EPT  
Date Received03/26/2019
Decision Date 10/10/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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