The following data is part of a premarket notification filed by Luneau Laboratories with the FDA for Skiascopic Racks.
| Device ID | K844364 |
| 510k Number | K844364 |
| Device Name: | SKIASCOPIC RACKS |
| Classification | Rack, Skiascopic |
| Applicant | LUNEAU LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HMH |
| CFR Regulation Number | 886.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-01-02 |