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.
Device ID | K213317 |
510k Number | K213317 |
Device Name: | ShinEvac Smoke Evacuation Pencil |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Shining World Health Care Co., Ltd. No.22, Ln. 116, Wugong 2nd Rd., Wugu Dist New Taipei City, TW 248 |
Contact | Anita Chen |
Correspondent | Anita Chen Shining World Health Care Co., Ltd. No.22, Ln. 116, Wugong 2nd Rd., Wugu Dist New Taipei City, TW 248 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-10-04 |
Decision Date | 2022-01-28 |