510(k) K060948 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PORTRAIT PSR3
| Applicant | Rhytec Incorporated, North Reading MA, US |
| Decision | Substantially Equivalent, Sep 5, 2006 |
| Received | Apr 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060948
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2007 | Rhytec Inc. Portrait PSR3 System, an electro-surgical device used in dermatological applications Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.