| Device Classification Name |
Light, Surgical, Ceiling Mounted
|
| 510(k) Number |
K902864 |
| Device Name |
SURGICAL LIGHTING-CENTRA 450 |
| Applicant |
| Sds Dental, Inc. |
| 5101 NW 21st Ave. NW |
| Suite 141 |
|
Fort Lauderdale,
FL
33309
|
|
| Applicant Contact |
CESAR R CORAL |
| Correspondent |
| Sds Dental, Inc. |
| 5101 NW 21st Ave. NW |
| Suite 141 |
|
Fort Lauderdale,
FL
33309
|
|
| Correspondent Contact |
CESAR R CORAL |
| Regulation Number | 878.4580 |
| Classification Product Code |
|
| Date Received | 06/29/1990 |
| Decision Date | 09/10/1990 |
| 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
|