The following data is part of a premarket notification filed by Rhytec Incorporated with the FDA for Portrait Psr.
Device ID | K071786 |
510k Number | K071786 |
Device Name: | PORTRAIT PSR |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | RHYTEC INCORPORATED 130 TURNER STREET Waltham, MA 02453 |
Contact | Robert Zoletti |
Correspondent | Robert Zoletti RHYTEC INCORPORATED 130 TURNER STREET 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 | 2007-07-02 |
Decision Date | 2007-07-26 |
Summary: | summary |