The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr Ii Electrosurgical System Coolpluse 90 And Coolpluse 90 With Han.
| Device ID | K113545 |
| 510k Number | K113545 |
| Device Name: | VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN |
| 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 | 2011-12-01 |
| Decision Date | 2012-02-27 |
| Summary: | summary |