FDA 510(k) Applications for Medical Device Product Code "NAE"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K082865 | GORBEC PHARMACEUTICAL SERVICES, INC. | MODIFICATION TO ZENIEVA | 10/23/2008 |
K073246 | GORBEC PHARMACEUTICAL SERVICES, INC. | ZENIEVA | 07/23/2008 |
K083721 | RIVER'S EDGE PHARMACEUTICALS, LLC | MODIFICATION TO ZENIEVA | 01/08/2009 |