| Device Classification Name |
Instrument, Surgical, Disposable
|
| 510(k) Number |
K820158 |
| Device Name |
OLSEN #770 DISPOSABLE HOLSTER |
| Applicant |
| Olsen Electro-Surgical Instruments, Inc. |
|
Anaheim,
CA
|
|
| Correspondent |
| Olsen Electro-Surgical Instruments, Inc. |
|
Anaheim,
CA
|
|
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 01/20/1982 |
| Decision Date | 02/05/1982 |
| 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
|