Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K973682 |
Device Name |
BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, |
Applicant |
ELECTROSCOPE, INC. |
4828 STERLING DR. |
BOULDER,
CO
80301
|
|
Applicant Contact |
JANE E JOHNSON |
Correspondent |
ELECTROSCOPE, INC. |
4828 STERLING DR. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
JANE E JOHNSON |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/26/1997 |
Decision Date | 12/18/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|