The following data is part of a premarket notification filed by Unimed Surgical Products, Inc. with the FDA for Unimed Coated Laparoscopic/arthroscopy/suction-irrigation Electrode.
| Device ID | K970066 |
| 510k Number | K970066 |
| Device Name: | UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION 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 | 1997-01-08 |
| Decision Date | 1997-02-18 |
| Summary: | summary |