The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Vapr Vue Radiofrequency System ,model 225024, Vpr Vue Wireless Footswitch, Model 227214.
| Device ID | K100638 |
| 510k Number | K100638 |
| Device Name: | VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 |
| 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 | 2010-03-05 |
| Decision Date | 2010-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705009657 | K100638 | 000 |