Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K103017 |
Device Name |
MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE |
Applicant |
MEDERI THERAPEUTICS INC. |
80 SHELTON TECHNOLOGY CENTER |
SHELTON,
CT
06484
|
|
Applicant Contact |
CURT RAYMOND |
Correspondent |
MEDERI THERAPEUTICS INC. |
80 SHELTON TECHNOLOGY CENTER |
SHELTON,
CT
06484
|
|
Correspondent Contact |
CURT RAYMOND |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 10/12/2010 |
Decision Date | 01/20/2011 |
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
|