Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K850943 |
Device Name |
MODEL 775 BIPOLAR COAGULATOR |
Applicant |
BIRTCHER CORP. |
4501 N. ARDEN DR. |
P.O. BOX 4399 |
EL MONTE,
CA
91731
|
|
Applicant Contact |
DONALD L EMMONS |
Correspondent |
BIRTCHER CORP. |
4501 N. ARDEN DR. |
P.O. BOX 4399 |
EL MONTE,
CA
91731
|
|
Correspondent Contact |
DONALD L EMMONS |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/07/1985 |
Decision Date | 05/20/1985 |
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
|