This page includes the latest FDA filings for Robert Ballantine. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Robert Ballantine holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3009212453 | ||||||||||
| FEI Number | 3009212453 | ||||||||||
| Name | Robert Ballantine | ||||||||||
| Owner & Operator | ELvation Medical GmbH | ||||||||||
| Contact Address | Ludwig-Wolf-Str. 6 Kieselbronn DE-BW Baden-Wurttemberg 75249 DE | ||||||||||
| Official Correspondent |
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| US Agent |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||||||
| Initial Importer | N | ||||||||||
| Registration Expiration | 2020-04-25 | ||||||||||
| Registration Address | 1327 4th St Hudson, WI 54016 US | ||||||||||
| Establishment Type | Export Device to the United States But Perform No Other Operation on Device |
| Registration Number | 3009307605 |
| FEI Number | 3009307605 |
| Name | Robert Ballantine |
| Owner & Operator | Lojer Oy |
| Contact Address | Putajantie 42 Sastamala FI-LS Lansi-Suomen laani FIN-38210 FI |
| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2220 Northmont Parkway Duluth, GA 30096 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
Robert Ballantine [ELvation Medical GmbH] | 3000950 | 2018-06-19 |
Robert Ballantine [ELvation Medical GmbH] | Piezolith 3000 | 2017-12-06 |
Robert Ballantine [Lojer Oy] | Lojer Manuthera 242 | 2017-01-16 |
Robert Ballantine [Lojer Oy] | Lojer Capre M Treatment Table | 2017-01-16 |
Robert Ballantine [Lojer Oy] | Lojer Capre FX Treatment Table | 2017-01-16 |
Robert Ballantine [Lojer Oy] | Lojer Capre F Treatment Table | 2017-01-16 |
Robert Ballantine [ELvation Medical GmbH] | PiezoWave 2 MyACT | 2012-11-07 |