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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 K213060
Device Name AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
Applicant
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd.
Nanjing National Hi-Tech Industrial Development Zone
Nanjing,  CN 210032
Applicant Contact Sally He
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd.
Nanjing National Hi-Tech Industrial Development Zone
Nanjing,  CN 210032
Correspondent Contact Sally He
Regulation Number874.4680
Classification Product Code
KTI  
Date Received09/22/2021
Decision Date 07/20/2022
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
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