510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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|---|---|---|---|
| vial adapter ø20 mm , vial adapter ø13 mm | Avenir Performance Europeenne Medical (APEM) | k190816 |
11/19/2019 |
| gsp neonatal total galactose kit | PerkinElmer Inc. | k190335 |
11/06/2019 |
| pulse oximeter | Shenzhen Yimi Life-Technology Co.,Ltd. | k191430 |
10/18/2019 |
| human iga liquid reagent kit for use on spaplus | The Binding Site Group Ltd | k192116 |
09/04/2019 |
| 980nm diode laser therapy device | Shanghai Apolo Medical Technology Co., Ltd. | k191349 |
08/16/2019 |
| modular power standing system | Motion Concepts | k191376 |
08/13/2019 |
| aocup lens case with aodisc | Alcon Laboratories, Inc. | k191795 |
07/31/2019 |
| solax powered wheelchair | Dongguan Prestige Sporting Goods Co., Ltd | k182576 |
05/21/2019 |
| preat abutments | Preat Corporation | k183518 |
03/18/2019 |
| planet onco dose | DOSIsoft | k182966 |
03/06/2019 |
| * The maximum 500 records meeting your search criteria returned. Please narrow your search. |
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