The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Fiber Optic Headlight #60-0765.
| Device ID | K802769 |
| 510k Number | K802769 |
| Device Name: | FIBER OPTIC HEADLIGHT #60-0765 |
| Classification | Headlight, Fiberoptic Focusing |
| Applicant | ASPEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FCT |
| CFR Regulation Number | 886.4335 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-03 |
| Decision Date | 1980-12-11 |