ShinEvac Smoke Evacuation Pencil

Electrosurgical, Cutting & Coagulation & Accessories

Shining World Health Care Co., Ltd.

The following data is part of a premarket notification filed by Shining World Health Care Co., Ltd. with the FDA for Shinevac Smoke Evacuation Pencil.

Pre-market Notification Details

Device IDK213317
510k NumberK213317
Device Name:ShinEvac Smoke Evacuation Pencil
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Shining World Health Care Co., Ltd. No.22, Ln. 116, Wugong 2nd Rd., Wugu Dist New Taipei City,  TW 248
ContactAnita Chen
CorrespondentAnita Chen
Shining World Health Care Co., Ltd. No.22, Ln. 116, Wugong 2nd Rd., Wugu Dist New Taipei City,  TW 248
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-04
Decision Date2022-01-28

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