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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K181994
Device Name Single Use Aspiration Needle NA-U201H
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-Cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
Olympus Surgical Technologies America
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact Mary Anne Patella
Regulation Number876.1075
Classification Product Code
FCG  
Date Received07/26/2018
Decision Date 10/31/2018
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
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