The following data is part of a premarket notification filed by Mirrorme3d, Llc with the FDA for Mirrorme3d Modeling System.
Device ID | K212981 |
510k Number | K212981 |
Device Name: | MirrorMe3D Modeling System |
Classification | System, Image Processing, Radiological |
Applicant | MirrorMe3D, LLC 222 W 37th St., Suite 1501 New York, NY 10018 |
Contact | Jordan Mills |
Correspondent | Jordan Mills MirrorMe3D, LLC 222 W 37th St., Suite 1501 New York, NY 10018 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-17 |
Decision Date | 2022-04-22 |