The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Vapr 3 Electrosurgical System And Vapr Ld And Lp Suction Electrodes.
| Device ID | K041135 |
| 510k Number | K041135 |
| Device Name: | VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES |
| Classification | Arthroscope |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Ruth C Forstadt |
| Correspondent | Ruth C Forstadt DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-30 |
| Decision Date | 2004-05-10 |
| Summary: | summary |