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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 K230650
Device Name Monopolar Electrode Surgical Instrument
Applicant
Vhmed (Nantong) Co. , Ltd.
A1, 173 Ganjiang Rd.
Tongzhou Bay,  CN 226332
Applicant Contact Guan Yunjuan
Correspondent
P&L Scientific, Inc.
1430 S. Dixie Hwy Suite 105
Coral Gables,  FL  33146
Correspondent Contact Jun Peng
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/09/2023
Decision Date 10/12/2023
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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