The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Fiber Optic Light Source.
| Device ID | K801176 |
| 510k Number | K801176 |
| Device Name: | FIBER OPTIC LIGHT SOURCE |
| Classification | Source, Carrier, Fiberoptic Light |
| Applicant | ASPEN LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-16 |
| Decision Date | 1980-05-28 |