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 |