| Device Classification Name |
Table And Attachments, Operating-Room
|
| 510(k) Number |
K852332 |
| Device Name |
TABLE ACCESSORIES, OPERATING ROOM |
| Applicant |
| Scholten Surgical Instruments, Inc. |
| 707 Warrington Ave. |
|
Redwood City,
CA
94063
|
|
| Applicant Contact |
JACOBUS SCHOLTEN |
| Correspondent |
| Scholten Surgical Instruments, Inc. |
| 707 Warrington Ave. |
|
Redwood City,
CA
94063
|
|
| Correspondent Contact |
JACOBUS SCHOLTEN |
| Regulation Number | 878.4950 |
| Classification Product Code |
|
| Date Received | 05/31/1985 |
| Decision Date | 07/02/1985 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|