The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Fiber Optic Adapters#60-0891.
| Device ID | K810299 |
| 510k Number | K810299 |
| Device Name: | FIBER OPTIC ADAPTERS#60-0891 |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | ASPEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-03 |
| Decision Date | 1981-02-27 |