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 |