Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K122092 |
Device Name |
MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM |
Applicant |
MEDRANGE CORPORATION |
480 Apollo St Ste D |
Brea,
CA
92821
|
|
Applicant Contact |
KUOFANG HUANG |
Correspondent |
MEDRANGE CORPORATION |
480 Apollo St Ste D |
Brea,
CA
92821
|
|
Correspondent Contact |
KUOFANG HUANG |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/16/2012 |
Decision Date | 10/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|