The following data is part of a premarket notification filed by Moyco Industries, Inc. with the FDA for Fixident.
| Device ID | K821629 |
| 510k Number | K821629 |
| Device Name: | FIXIDENT |
| Classification | Pick, Massaging |
| Applicant | MOYCO INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JET |
| CFR Regulation Number | 872.6650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-02 |
| Decision Date | 1982-06-14 |