The following data is part of a premarket notification filed by Unimed Surgical Products, Inc. with the FDA for Surgi-link Lletz Needle Electrode, Loop Electrode, Square Loop Electrode.
| Device ID | K944450 |
| 510k Number | K944450 |
| Device Name: | SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE |
| Classification | Electrocautery, Gynecologic (and 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 | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-12 |
| Decision Date | 1995-07-25 |