Device Classification Name |
Electrosurgical Device
|
510(k) Number |
K925708 |
Device Name |
DISPOSABLE ELECTROSURGERY BALL ELECTRODE |
Applicant |
BEACON LABORATORIES, INC. |
2150 WEST 6TH AVE., UNIT P |
BROOMFIELD,
CO
80020
|
|
Applicant Contact |
RICHARD P FLEENOR |
Correspondent |
BEACON LABORATORIES, INC. |
2150 WEST 6TH AVE., UNIT P |
BROOMFIELD,
CO
80020
|
|
Correspondent Contact |
RICHARD P FLEENOR |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/12/1992 |
Decision Date | 04/20/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|