The following data is part of a premarket notification filed by Medrange Corporation with the FDA for Medrange Electrosurgical Generator.
Device ID | K102114 |
510k Number | K102114 |
Device Name: | MEDRANGE ELECTROSURGICAL GENERATOR |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MEDRANGE CORPORATION 480 APOLLO STREET, SUITE D BREA, Los Angeles, CA 92821 |
Contact | Harry Woods |
Correspondent | Harry Woods MEDRANGE CORPORATION 480 APOLLO STREET, SUITE D BREA, Los Angeles, 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 | 2010-07-28 |
Decision Date | 2010-11-22 |
Summary: | summary |