| Device Classification Name |
Table, Operating-Room, Ac-Powered
|
| 510(k) Number |
K953980 |
| Device Name |
KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT |
| Applicant |
| Kreuzer Corp. |
| 1615 Buckingham Dr. |
|
Murfreesboro,
TN
37129
|
|
| Applicant Contact |
DAIVD A HOKE |
| Correspondent |
| Kreuzer Corp. |
| 1615 Buckingham Dr. |
|
Murfreesboro,
TN
37129
|
|
| Correspondent Contact |
DAIVD A HOKE |
| Regulation Number | 878.4960 |
| Classification Product Code |
|
| Date Received | 08/23/1995 |
| Decision Date | 11/16/1995 |
| 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
|