The following data is part of a premarket notification filed by Henry Schein, Inc. with the FDA for Fiberglass Mouth Mirrors.
| Device ID | K841199 |
| 510k Number | K841199 |
| Device Name: | FIBERGLASS MOUTH MIRRORS |
| Classification | Mirror, Mouth |
| Applicant | HENRY SCHEIN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EAX |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-21 |
| Decision Date | 1984-04-25 |