Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K973234 |
Device Name |
MIDAS TOUCH ELECTROSURGICAL ELECTRODE |
Applicant |
ITI MEDICAL TECHNOLOGIES, INC. |
2452 ARMSTRONG ST. |
LIVERMORE,
CA
94550
|
|
Applicant Contact |
ROGER WERNE |
Correspondent |
ITI MEDICAL TECHNOLOGIES, INC. |
2452 ARMSTRONG ST. |
LIVERMORE,
CA
94550
|
|
Correspondent Contact |
ROGER WERNE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/28/1997 |
Decision Date | 10/27/1997 |
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
|
Recalls |
CDRH Recalls
|