FDA 510(k) Applications for Medical Device:
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
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 |
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 |
|
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