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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K193601
Device Name Single Use Electrosurgical Knife
Applicant
Micro-Tech (Nanjing) Co., Ltd.
#10 Gaoke Third Rd.
Nanjing,  CN 210032
Applicant Contact Sally He
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
#10 Gaoke Third Rd.
Nanjing,  CN 210032
Correspondent Contact Sally He
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
KNS  
Date Received12/23/2019
Decision Date 07/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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