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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K220069
Device Name 4K UHD LCD Monitor OEV321UH
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 Elizabeth Greene
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/10/2022
Decision Date 03/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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