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 |