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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K221522
Device Name HF-cables (resusable)
Applicant
Olympus Winter & Ibe Gmbh
Kuehnstr. 61
Hamburg,  DE 22045
Applicant Contact Lilly Omland
Correspondent
Olympus Surgical Technologies of the Americas
800 West Park Drive
Westborough,  MA  01581
Correspondent Contact Christina Flores
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/26/2022
Decision Date 01/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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