The following data is part of a premarket notification filed by Rhytec Incorporated with the FDA for Portrait Psr3.
Device ID | K060948 |
510k Number | K060948 |
Device Name: | PORTRAIT PSR3 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | RHYTEC INCORPORATED 5 TIMBER LANE North Reading, MA 01864 |
Contact | Maureen O'connell |
Correspondent | Maureen O'connell RHYTEC INCORPORATED 5 TIMBER LANE North Reading, MA 01864 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-06 |
Decision Date | 2006-09-05 |
Summary: | summary |