| Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
| 510(k) Number |
K760722 |
| Device Name |
BIRT-A-CHUCK DISPOSABLE ELECTR. HANDLE |
| Applicant |
| Birtcher Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Birtcher Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 878.4400 |
| Classification Product Code |
|
| Date Received | 09/27/1976 |
| Decision Date | 11/01/1976 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|