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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K192498
Device Name Single Use Injector
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-machi
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 Sheri L. Musgnung
Regulation Number876.1500
Classification Product Code
FBK  
Date Received09/11/2019
Decision Date 04/28/2020
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
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