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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 K213317
Device Name ShinEvac Smoke Evacuation Pencil
Applicant
Shining World Health Care Co., Ltd.
No.22, Ln. 116, Wugong 2nd Rd., Wugu Dist
New Taipei City,  TW 248
Applicant Contact Anita Chen
Correspondent
Shining World Health Care Co., Ltd.
No.22, Ln. 116, Wugong 2nd Rd., Wugu Dist
New Taipei City,  TW 248
Correspondent Contact Anita Chen
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/04/2021
Decision Date 01/28/2022
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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