The following data is part of a premarket notification filed by Relievant Medsystems, Inc. with the FDA for Intracept Bi-polar Rf Probe, Model 04814.
| Device ID | K070443 |
| 510k Number | K070443 |
| Device Name: | INTRACEPT BI-POLAR RF PROBE, MODEL 04814 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RELIEVANT MEDSYSTEMS, INC. 713 SANDOVAL WAY Hayward, CA 94544 |
| Contact | Mark Smutka |
| Correspondent | Mark Smutka RELIEVANT MEDSYSTEMS, INC. 713 SANDOVAL WAY Hayward, CA 94544 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-15 |
| Decision Date | 2007-10-05 |
| Summary: | summary |