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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 K182408
Device Name Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
Olympus Surgical Technologies America
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact Daphney Germain-Kolawole
Regulation Number876.4300
Classification Product Code
KNS  
Date Received09/04/2018
Decision Date 05/15/2019
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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