The following data is part of a premarket notification filed by Henry Schein, Inc. with the FDA for Kwix-bite X-ray Film Holder.
| Device ID | K801079 |
| 510k Number | K801079 |
| Device Name: | KWIX-BITE X-RAY FILM HOLDER |
| Classification | Holder, Film, X-ray |
| Applicant | HENRY SCHEIN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EGZ |
| CFR Regulation Number | 872.1905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-07 |
| Decision Date | 1980-05-20 |