The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Model 8750 Bipolar/monopolar Electrosurgical Gene..
| Device ID | K895841 |
| 510k Number | K895841 |
| Device Name: | MODEL 8750 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENE. |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EVEREST MEDICAL CORP. 6601 SHINGLE CREEK PKWY. SUITE 400 Brooklyn Center, MN 55430 |
| Contact | David Parins |
| Correspondent | David Parins EVEREST MEDICAL CORP. 6601 SHINGLE CREEK PKWY. SUITE 400 Brooklyn Center, MN 55430 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-02 |
| Decision Date | 1989-11-15 |