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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bronchoscope (flexible or rigid)
510(k) Number K213782
Device Name Single-Use Video Bronchoscopes, Digital Controller
Applicant
Micro-Tech (Nanjing) Co., Lts
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial
Development Zone
Nanjing,  CN 210032
Applicant Contact Sally He
Correspondent
Micro-Tech (Nanjing) Co., Lts
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial
Development Zone
Nanjing,  CN 210032
Correspondent Contact Sally He
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received12/03/2021
Decision Date 07/08/2022
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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