The following data is part of a premarket notification filed by F Care Systems Nv with the FDA for Evrf System.
| Device ID | K130283 |
| 510k Number | K130283 |
| Device Name: | EVRF SYSTEM |
| Classification | Electrosurgical Coagulation For Aesthetic |
| Applicant | F CARE SYSTEMS NV 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | E. J Smith |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | ONQ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-02-05 |
| Decision Date | 2013-03-07 |
| Summary: | summary |