The following data is part of a premarket notification filed by Sds Dental, Inc. with the FDA for Surgical Lighting-centra 450.
| Device ID | K902864 |
| 510k Number | K902864 |
| Device Name: | SURGICAL LIGHTING-CENTRA 450 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 Fort Lauderdale, FL 33309 |
| Contact | Cesar R Coral |
| Correspondent | Cesar R Coral SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 Fort Lauderdale, FL 33309 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-29 |
| Decision Date | 1990-09-10 |