| Device Classification Name |
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
|
| 510(k) Number |
K922056 |
| Device Name |
HHI ELECTRIC CONSOLE #875-000 |
| Applicant |
| H&H Instruments |
| 4950 Crescent Technical Ct. |
|
St Augustine,
FL
32086
|
|
| Applicant Contact |
MARY K HORVATH |
| Correspondent |
| H&H Instruments |
| 4950 Crescent Technical Ct. |
|
St Augustine,
FL
32086
|
|
| Correspondent Contact |
MARY K HORVATH |
| Regulation Number | 878.4820 |
| Classification Product Code |
|
| Date Received | 05/04/1992 |
| Decision Date | 09/18/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|