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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 K203494
Device Name Nissha Medical Technologies Neutral Electrodes
Applicant
Nissha Medical Technologies LTD
Torbay Business Park, Woodview Road
Paignton,  GB TQ4 7HP
Applicant Contact Marcel Salchner
Correspondent
Nissha Medical Technologies LTD
Torbay Business Park, Woodview Road
Paignton,  GB TQ4 7HP
Correspondent Contact Marcel Salchner
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/27/2020
Decision Date 02/23/2021
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
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