The following data is part of a premarket notification filed by Magne-dent with the FDA for Magne-dent.
Device ID | K840600 |
510k Number | K840600 |
Device Name: | MAGNE-DENT |
Classification | Attachment, Precision, All |
Applicant | MAGNE-DENT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EGG |
CFR Regulation Number | 872.3165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-10 |
Decision Date | 1984-04-30 |