The following data is part of a premarket notification filed by Unimed Surgical Products, Inc. with the FDA for Unimed Coated Needle Electrode/coated Blade Electrode/coated Ball Electrode.
| Device ID | K962935 |
| 510k Number | K962935 |
| Device Name: | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo, FL 34647 |
| Contact | Ronald R Froemming |
| Correspondent | Ronald R Froemming 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 | 1996-07-29 |
| Decision Date | 1996-09-03 |
| Summary: | summary |