The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Side Effect With Hand Controls, Hook Electrode With Hand Controls, 2.3 Wedge Electrode With Hand Controls, S90 With Hand.
| Device ID | K120095 |
| 510k Number | K120095 |
| Device Name: | SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Susan Kagan |
| Correspondent | Susan Kagan 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-12 |
| Decision Date | 2012-04-06 |
| Summary: | summary |