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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 |
|---|---|---|---|---|---|
| K183015 | 3-D Matrix, Inc. |
250 First Ave., Suite 205 | Needham | MA | 02494 |
| K192661 | Entellus Medical, Inc. (Aka Stryker ENT) |
3600 Holly Lane North, Suite 40 | Plymouth | MN | 55447 |
| K092590 | ETHICON, INC. |
U.S. ROUTE 22, WEST | SOMERVILLE | NJ | 08876-0151 |
| K210411 | Hemostasis LLC |
5000 Township Pkwy | St Paul | MN | 55110 |
| K012769 | MACROPORE BIOSURGERY, INC. |
6740 TOP GUN ST. | SAN DIEGO | CA | 92121 |
| K070886 | MEDTRONIC INC. |
6743 SOUTHPOINT DRIVE NORTH | JACKSONVILLE | FL | 32259 |
| K122434 | MEDTRONIC XOMED |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K070715 | Polyganics BV |
L.J. ZIELSTRAWEG 1 | GRONINGEN | 9713-GX | |
| K233569 | Spirair, Inc. |
415 Grand Avenue | San Francisco | CA | 94080 |
| K223167 | Spirair, Inc. |
6084 Monterey Hwy, 108 | San Jose | CA | 95138 |
| K152958 | SPIROX, INC. |
3475-O EDISON WAY | MENLO PARK | CA | 94025 |
| K161191 | SPIROX, INC. |
3475-O EDISON WAY | MENLO PARK | CA | 94025 |
| K132920 | SPIROX, INC. |
381 ARLINGTON WAY | MENLO PARK | CA | 94025 |
| K012409 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |