The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Bipolar Electrosurgical Snare.
| Device ID | K893553 |
| 510k Number | K893553 |
| Device Name: | BIPOLAR ELECTROSURGICAL SNARE |
| Classification | Snare, Flexible |
| 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 | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-08 |
| Decision Date | 1989-09-08 |