The following data is part of a premarket notification filed by Suncoast Medical Manufacturers, Inc. with the FDA for Flexible Illuminator 10.
| Device ID | K840373 |
| 510k Number | K840373 |
| Device Name: | FLEXIBLE ILLUMINATOR 10 |
| Classification | Illuminator, Non-remote |
| Applicant | SUNCOAST MEDICAL MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FTF |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-27 |
| Decision Date | 1984-04-24 |