The following data is part of a premarket notification filed by Medtrex, Inc. with the FDA for Electrosurgical Dispersive Electrode.
| Device ID | K952577 |
| 510k Number | K952577 |
| Device Name: | ELECTROSURGICAL DISPERSIVE ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTREX, INC. 14 INVERNESS DRIVE EAST BUILDING F, SUITE 124 Englewood, CO 80112 |
| Contact | Paul P Burek |
| Correspondent | Paul P Burek MEDTREX, INC. 14 INVERNESS DRIVE EAST BUILDING F, SUITE 124 Englewood, CO 80112 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-05 |
| Decision Date | 1995-06-14 |