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FDA 510(k) Applications for Medical Device:
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| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K231256 | Carecubes, Inc. |
3101 20th Street | San Francisco | CA | 94110 |
| K080117 | GENTEX CORPORATION |
11525 SIXTH ST. | RANCHO CUCAMONGA | CA | 91730 |
| K022260 | ISOLATION SYSTEMS, INC. |
79 FILLMORE AVE. | TONAWANDA | NY | 14150-2335 |
| K163223 | ISOVAC PRODUCTS, LLC |
1306 ENTERPRISE DRIVE, UNIT C | ROMEOVILLE | IL | 60446 |