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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 K211894
Device Name Trachealator
Applicant
DISA Medinotec
Stand 171, Northlands Business Park, Bush Telegraph Street
Northriding
Johannesburg,  ZA 2169
Applicant Contact Michelle Nieuwoudt
Correspondent
Biologics Consulting Group, Inc.
1555 King Street, Suite 300
Alexandria,  VA  22314
Correspondent Contact Matthew Krueger
Regulation Number874.4680
Classification Product Code
KTI  
Date Received06/21/2021
Decision Date 11/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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