The following data is part of a premarket notification filed by Shining World Health Care Co., Ltd. with the FDA for Shinmed Various Models Of Electro-surgical Pencils, Sw12200, Sw12202, Sw12300.
| Device ID | K033027 |
| 510k Number | K033027 |
| Device Name: | SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SHINING WORLD HEALTH CARE CO., LTD. 6F, NO. 8, LANE 7, WU-CHUN RD. WU-KU INDUSTRIAL PARK Taipei Hsien, TW 24886 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min SHINING WORLD HEALTH CARE CO., LTD. 6F, NO. 8, LANE 7, WU-CHUN RD. WU-KU INDUSTRIAL PARK Taipei Hsien, TW 24886 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-26 |
| Decision Date | 2004-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712803070116 | K033027 | 000 |