The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Co2 Laser Bronchoscope Coupler.
| Device ID | K894962 |
| 510k Number | K894962 |
| Device Name: | CO2 LASER BRONCHOSCOPE COUPLER |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-07 |
| Decision Date | 1989-09-28 |