The following data is part of a premarket notification filed by Unimed Surgical Products, Inc. with the FDA for Surgi-link Disposable Push Button Esu Pencil.
| Device ID | K944617 |
| 510k Number | K944617 |
| Device Name: | SURGI-LINK DISPOSABLE PUSH BUTTON ESU PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo, FL 33777 |
| Contact | Lorna Linville |
| Correspondent | Lorna Linville UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo, FL 33777 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-20 |
| Decision Date | 1994-09-29 |