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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K220247
Device Name Guidewire Locking Device
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 Number876.1500
Classification Product Code
ODC  
Date Received01/28/2022
Decision Date 03/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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