FDA 510(k) Applications for Medical Device:
Tube, Tympanostomy
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K103595 | ACCLARENT, INC. |
1525-B O'BRIEN DR. | MENLO PARK | CA | 94025 |
| K082188 | ACCLARENT, INC. |
1525-B O'BRIEN DR. | MENLO PARK | CA | 94025 |
| K061058 | ADEPT MEDICAL LTD |
P.O. BOX 10075 | AUCKLAND | ||
| K960742 | ADVANCED MICROBOTICS CORP. |
2611 S.W. 3RD. AVE., SUITE 200 | PORTLAND | OR | 97201 |
| K961945 | ADVANCED MICROBOTICS CORP. |
2611 S.W. 3RD. AVE., SUITE 200 | PORTLAND | OR | 97201 |
| K232702 | AventaMed DAC |
Rubicon Centre, Rossa Avenue, | Bishopstown | T12 Y275 | |
| K250256 | AventaMed DAC |
Rubicon Centre | Bishopstown | T12 Y275 | |
| K233658 | Biowy Corporation |
27031 Vista Terrace | Lake Forest | CA | 92630 |
| K011383 | DURECT CORP. |
10240 BUBB RD. | CUPERTINO | CA | 95014 |
| K980828 | EXMOOR PLASTICS LTD. |
LISIEUX WAY | TAUNTON, SOMERSET | TA1 2LB | |
| K974008 | EXMOOR PLASTICS LTD. |
LISIEUX WAY | TAUNTON, SOMERSET | TA1 2LB | |
| K974007 | EXMOOR PLASTICS LTD. |
LISIEUX WAY | TAUNTON, SOMERSET | TA1 2LB | |
| K062385 | Grace Medical, Inc. |
8500 WOLF LAKE DR., STE. 110 | MEMPHIS | TN | 38133 |
| K062672 | Grace Medical, Inc. |
8500 WOLF LAKE DR., STE. 110 | MEMPHIS | TN | 38133 |
| K981575 | Grace Medical, Inc. |
7715 HWY. 70, SUITE 109 | BARTLETT | TN | 38133 |
| K232059 | Grace Medical, Inc. |
8500 Wolf Lake Drive, Suite 110 | Memphis | TN | 38133 |
| K992222 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K000801 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K071150 | HEINZ KURZ GMBH MEDIZINTECHNIK |
AMSTEL 320-1 | AMSTERDAM | D-72144 | |
| K973226 | HEINZ KURZ GMBH MEDIZINTECHNIK |
TUBINGER STRASSE 3 | DUSSLINGEN | D-72144 | |
| K971454 | IKONOS CORP. |
320 S.W. 6TH. AVE., 2ND. FL. | PORTLAND | OR | 97204 |
| K971943 | MEDNET LOCATOR, INC. |
7000 SHADOW OAKS | MEMPHIS | TN | 38125 |
| K972126 | MEDNET LOCATOR, INC. |
7000 SHADOW OAKS | MEMPHIS | TN | 38125 |
| K972400 | MEDNET LOCATOR, INC. |
7000 SHADOW OAKS | MEMPHIS | TN | 38125 |
| K963727 | MEDTRONIC XOMED |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K151067 | Medtronic Xomed, Inc. |
6743 Southpoint Drive North | Jacksonville | FL | 32216 |
| K991670 | MICROMEDICS, INC. |
1285 CORPORATE CENTER DR., | EAGAN | MN | 55121 |
| K955616 | MISTEN MEDICAL CORP. |
7220 STOUT RD. | GERMANTOWN | TN | 38138 |
| K965115 | NEURO-BIOMETRIX, INC. |
3151 S. ALBION ST. | DENVER | CO | 80222 |
| K973740 | NEURO-BIOMETRIX, INC. |
7995 EAST PRENTICE AVE. | ENGLEWOOD | CO | 80111-2710 |
| K071178 | OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD. |
20 HATA'AS ST. | KFAR SABA | 44425 | |
| K151830 | PRECEPTIS MEDICAL |
505 HIGHWAY 169 NORTH, #365 | PLYMOUTH | MN | 55441 |
| K142282 | PRECEPTIS MEDICAL |
505 HIGHWAY 169 NORTH, #365 | PLYMOUTH | MN | 55441 |
| K133921 | PRECEPTIS MEDICAL |
505 HIGHWAY 169 NORTH, #365 | PLYMOUTH | MN | 55441 |
| K200952 | Preceptis Medical, Inc |
10900 89th Ave N | Maple Grove | MN | 55369 |
| K221254 | Preceptis Medical, Inc. |
10900 89th Avenue North, Suite 4 | Maple Grove | MN | 55369 |
| K960477 | SMITH & NEPHEW, INC. |
555 13TH ST., N.W. | WASHINGTON | DC | 20004 |
| K171239 | Tusker Medical |
155 Jefferson Drive Suite 200 | Menlo Park | CA | 94025 |
| K961873 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
| K971124 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
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