The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Fiberoptic Headlight System.
| Device ID | K893458 |
| 510k Number | K893458 |
| Device Name: | FIBEROPTIC HEADLIGHT SYSTEM |
| Classification | Light, Surgical Headlight |
| Applicant | CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Contact | Cynthia Arcusa |
| Correspondent | Cynthia Arcusa CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Product Code | EBA |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-02 |
| Decision Date | 1989-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403067884 | K893458 | 000 |
| 10885403067877 | K893458 | 000 |