The following data is part of a premarket notification filed by 3d-side Sa with the FDA for Customize.
Device ID | K221432 |
510k Number | K221432 |
Device Name: | Customize |
Classification | Automated Radiological Image Processing Software |
Applicant | 3D-Side SA Rue Andre Dumont 5 Mont-Saint-Guibert, BE 1435 |
Contact | Laurent Paul |
Correspondent | Mieke Janssen OrthoGrow NV Davincilaan 1 Zaventem, BE 1930 |
Product Code | QIH |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-05-17 |
Decision Date | 2022-08-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CUSTOMIZE 98721069 not registered Live/Pending |
NINGBO LIYANG NEW MATERIAL COMPANY LIMITED 2024-08-28 |
CUSTOMIZE 98569987 not registered Live/Pending |
NINGBO LIYANG NEW MATERIAL COMPANY LIMITED 2024-05-27 |
CUSTOMIZE 86600227 4890591 Live/Registered |
NISSIN FOODS HOLDINGS CO., LTD. 2015-04-16 |
CUSTOMIZE 71468159 0408628 Dead/Expired |
K.J. QUINN & CO. INC. 1944-03-10 |