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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tracheal, Expandable
510(k) Number K212403
Device Name Tracheal Stent System (Y-Shaped)
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 Number878.3720
Classification Product Code
JCT  
Date Received08/02/2021
Decision Date 10/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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