The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Rf Lesion Cannula, Rf Thermolesion Cannula, Thermolesion Cannula, X-ray Contrast Cannula, Cannula, Facet Deneration Need.
| Device ID | K060397 |
| 510k Number | K060397 |
| Device Name: | RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, Baden-wurttemberg, DE 78187 |
| Contact | Christian Quass |
| Correspondent | Christian Quass PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, Baden-wurttemberg, DE 78187 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-15 |
| Decision Date | 2006-08-31 |
| Summary: | summary |