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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K171158
Device Name Single Use Electrosurgical knife
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 Daphney Germain-Kolawole
Regulation Number876.4300
Classification Product Code
KNS  
Date Received04/20/2017
Decision Date 11/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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