The following data is part of a premarket notification filed by Rhytec Incorporated with the FDA for Portrait Psr, Model 745915.
Device ID | K073111 |
510k Number | K073111 |
Device Name: | PORTRAIT PSR, MODEL 745915 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-05 |
Decision Date | 2008-03-27 |
Summary: | summary |