The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Genesis.
Device ID | K151485 |
510k Number | K151485 |
Device Name: | GENESIS |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
Contact | John Hoffer |
Correspondent | John Hoffer DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-02 |
Decision Date | 2015-06-30 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GENESIS 98503106 not registered Live/Pending |
Medical Education & Research Institute 2024-04-16 |
GENESIS 98436393 not registered Live/Pending |
Garcia, Haidy, E 2024-03-06 |
GENESIS 98371945 not registered Live/Pending |
Winpak Lane, Inc. 2024-01-23 |
GENESIS 98351442 not registered Live/Pending |
HYUNDAI MOTOR COMPANY 2024-01-10 |
GENESIS 98351438 not registered Live/Pending |
HYUNDAI MOTOR COMPANY 2024-01-10 |
GENESIS 98351433 not registered Live/Pending |
HYUNDAI MOTOR COMPANY 2024-01-10 |
GENESIS 98177985 not registered Live/Pending |
Genesis Distribution, Inc. 2023-09-13 |
GENESIS 98119528 not registered Live/Pending |
Badu, Crystal AC 2023-08-07 |
GENESIS 98091638 not registered Live/Pending |
ARKK Food Company 2023-07-19 |
GENESIS 98039943 not registered Live/Pending |
AgBiome, Inc. 2023-06-13 |
GENESIS 98039928 not registered Live/Pending |
AgBiome, Inc. 2023-06-13 |
GENESIS 97890595 not registered Live/Pending |
Strong Industries, Inc. 2023-04-16 |