The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Vapr P50 Suction Electrode Vapr S90 Suction Electrode Vapr P50 Suction Electrode With Handcontrols Vaprs90 Suction Elect.
| Device ID | K122425 |
| 510k Number | K122425 |
| Device Name: | VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Yayoi Fujimaki |
| Correspondent | Yayoi Fujimaki 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 | 2012-08-09 |
| Decision Date | 2012-11-05 |
| Summary: | summary |