The following data is part of a premarket notification filed by Optimed Therapeutics with the FDA for Laser Optical Fibers - Disposable.
| Device ID | K872870 |
| 510k Number | K872870 |
| Device Name: | LASER OPTICAL FIBERS - DISPOSABLE |
| Classification | Laser For Gastro-urology Use |
| Applicant | OPTIMED THERAPEUTICS P.O. BOX 7627 Hilton Head Island, SC 29938 |
| Contact | Robert N Fleming |
| Correspondent | Robert N Fleming OPTIMED THERAPEUTICS P.O. BOX 7627 Hilton Head Island, SC 29938 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-20 |
| Decision Date | 1987-10-14 |