The following data is part of a premarket notification filed by Kepler Medtec with the FDA for Kepler Medtec Disposable Bipolar Cable.
| Device ID | K110462 |
| 510k Number | K110462 |
| Device Name: | KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KEPLER MEDTEC 200 Homer Ave Ashland, MA 01721 |
| Contact | Sharyn Orton, Phd |
| Correspondent | Sharyn Orton, Phd KEPLER MEDTEC 200 Homer Ave Ashland, MA 01721 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-17 |
| Decision Date | 2011-09-26 |
| Summary: | summary |