The following data is part of a premarket notification filed by Unicep with the FDA for Microdose Rc-ez.
Device ID | K924825 |
510k Number | K924825 |
Device Name: | MICRODOSE RC-EZ |
Classification | Gutta-percha |
Applicant | UNICEP P.O. BOX 1827 804 AIRPORT WAY Sandpoint, ID 83864 |
Contact | John Snedden |
Correspondent | John Snedden UNICEP P.O. BOX 1827 804 AIRPORT WAY Sandpoint, ID 83864 |
Product Code | EKM |
CFR Regulation Number | 872.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-28 |
Decision Date | 1993-03-05 |