The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Smk Sluyter-mehta Cannulae, Rf Pole, Pole,flexible.
| Device ID | K870028 |
| 510k Number | K870028 |
| Device Name: | SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Contact | Cosman, Phd |
| Correspondent | Cosman, Phd RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-05 |
| Decision Date | 1987-10-26 |