The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Bitome(tm) Bipolar Sphincterotome.
| Device ID | K895842 |
| 510k Number | K895842 |
| Device Name: | BITOME(TM) BIPOLAR SPHINCTEROTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | EVEREST MEDICAL CORP. 13755 FIRST AVENUE, NORTH, SUITE 500 Minneapolis, MN 55441 -5444 |
| Contact | David Parins |
| Correspondent | David Parins EVEREST MEDICAL CORP. 13755 FIRST AVENUE, NORTH, SUITE 500 Minneapolis, MN 55441 -5444 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-02 |
| Decision Date | 1990-01-11 |