The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Bitx Probes.
| Device ID | K994336 |
| 510k Number | K994336 |
| Device Name: | BITX PROBES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EVEREST MEDICAL CORP. 13755 FIRST AVENUE, NORTH, SUITE 500 Minneapolis, MN 55441 -5444 |
| Contact | Frederick G Mades |
| Correspondent | Frederick G Mades EVEREST MEDICAL CORP. 13755 FIRST AVENUE, NORTH, SUITE 500 Minneapolis, MN 55441 -5444 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-02-08 |
| Summary: | summary |