The following data is part of a premarket notification filed by Medrange Corporation with the FDA for Medrange Electrosurgical Expansion System.
| Device ID | K122092 |
| 510k Number | K122092 |
| Device Name: | MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDRANGE CORPORATION 480 Apollo St Ste D Brea, CA 92821 |
| Contact | Kuofang Huang |
| Correspondent | Kuofang Huang MEDRANGE CORPORATION 480 Apollo St Ste D Brea, CA 92821 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2012-10-23 |
| Summary: | summary |