The following data is part of a premarket notification filed by Xoran Technologies, Inc. with the FDA for Minicat Dentocat.
Device ID | K032243 |
510k Number | K032243 |
Device Name: | MINICAT DENTOCAT |
Classification | System, X-ray, Tomography, Computed |
Applicant | XORAN TECHNOLOGIES, INC. 309 N. FIRST STREET Ann Arbor, MI 48103 |
Contact | Predrag Sukovic |
Correspondent | Predrag Sukovic XORAN TECHNOLOGIES, INC. 309 N. FIRST STREET Ann Arbor, MI 48103 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-22 |
Decision Date | 2003-10-02 |
Summary: | summary |