The following data is part of a premarket notification filed by Rhytec Incorporated with the FDA for Rhytec, Inc., Portrait Psr.
| Device ID | K082197 |
| 510k Number | K082197 |
| Device Name: | RHYTEC, INC., PORTRAIT PSR |
| 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 | 2008-08-04 |
| Decision Date | 2008-08-22 |
| Summary: | summary |