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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K193517
Device Name ViziShot 2 FLEX
Applicant
Olympus Surgical Technologies America
136 Turnpike Rd.
Southborough,  MA  01772 -2104
Applicant Contact Mary Anne Patella
Correspondent
Olympus Surgical Technologies America
136 Turnpike Rd.
Southborough,  MA  01772 -2104
Correspondent Contact Mary Anne Patella
Regulation Number874.4680
Classification Product Code
KTI  
Subsequent Product Code
FCG  
Date Received12/19/2019
Decision Date 03/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
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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