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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K160249
Device Name ULTRA Telescopes
Applicant
Olympus Winter & Ibe GmbH
Kuehnstr., 61
Hamburg,  DE 22045
Applicant Contact Katharina Campbell
Correspondent
Olympus Corporation of the Americas
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Sheri L. Musgnung
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/01/2016
Decision Date 04/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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