The following data is part of a premarket notification filed by Unimed Surgical Products, Inc. with the FDA for Surgi-link Bipolar Electrodes.
| Device ID | K944898 |
| 510k Number | K944898 |
| Device Name: | SURGI-LINK BIPOLAR ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo, FL 34647 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo, FL 34647 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-04 |
| Decision Date | 1994-11-01 |