The following data is part of a premarket notification filed by Rhytec Incorporated with the FDA for Portrait Stand-off.
| Device ID | K072394 |
| 510k Number | K072394 |
| Device Name: | PORTRAIT STAND-OFF |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RHYTEC INCORPORATED 130 TURNER STREET BUILDING 2 Waltham, MA 02453 |
| Contact | Robert Zoletti |
| Correspondent | Robert Zoletti RHYTEC INCORPORATED 130 TURNER STREET BUILDING 2 Waltham, MA 02453 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-27 |
| Decision Date | 2007-09-12 |
| Summary: | summary |