The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Model 8800 Bipolar Coagulation Therapeutic System.
| Device ID | K892895 |
| 510k Number | K892895 |
| Device Name: | MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | EVEREST MEDICAL CORP. 6601 SHINGLE CREEK PKWY. SUITE 400 Brooklyn Center, MN 55430 |
| Contact | Michael Hollenhorst |
| Correspondent | Michael Hollenhorst EVEREST MEDICAL CORP. 6601 SHINGLE CREEK PKWY. SUITE 400 Brooklyn Center, MN 55430 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1989-09-25 |