The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Model M2-150/i-150/m2-150t/m3-150/m2-150,300-300.
| Device ID | K893491 |
| 510k Number | K893491 |
| Device Name: | MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300 |
| Classification | Light, Surgical, Fiberoptic |
| 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 | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-04 |
| Decision Date | 1989-06-22 |