The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for 3.5 Mm Side Effect Electrode With Integrated Handpiece, Model 227301, 3.5 Mm Angled Side Effect Electrode With Integrate.
| Device ID | K082643 |
| 510k Number | K082643 |
| Device Name: | 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Zheng Liu |
| Correspondent | Zheng Liu DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-11 |
| Decision Date | 2008-12-19 |
| Summary: | summary |