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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K210934
Device Name Sphincterotome / short-wire compatible, Sterile Sphincterotome
Applicant
Micro-Tech (Nanjing) Co., Ltd.
No. 10 Gaoke Third Road,
Nanjing National Hi-tech Industrial Development Zone
Nanjing,  CN 210032
Applicant Contact Sally He
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
No. 10 Gaoke Third Road,
Nanjing National Hi-tech Industrial Development Zone
Nanjing,  CN 210032
Correspondent Contact Sally He
Regulation Number876.4300
Classification Product Code
KNS  
Date Received03/29/2021
Decision Date 12/01/2021
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
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