FDA 510(k) Applications for Medical Device:
Prosthesis, Partial Ossicular Replacement
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K964798 | ANTHONY D. PRESCOTT |
8624 NORTH LAKE COVE | MEMPHIS | TN | 38002 |
| K001142 | AUDIO TECHNOLOGIES S.R.L. |
VIA DELL'ARTIGINATO, 8 | PIACENZA | 29020 | |
| K981045 | EXMOOR PLASTICS LTD. |
LISIEUX WAY | TAUNTON, SOMERSET | TA1 2LB | |
| K974365 | EXMOOR PLASTICS LTD. |
LISIEUX WAY | TAUNTON | TA1 2LB | |
| K061853 | Grace Medical, Inc. |
8500 WOLF LAKE DR., STE. 110 | MEMPHIS | TN | 38133 |
| K080070 | Grace Medical, Inc. |
8500 WOLF LAKE DR., STE. 110 | MEMPHIS | TN | 38133 |
| K063374 | Grace Medical, Inc. |
8500 WOLF LAKE DR., STE. 110 | MEMPHIS | TN | 38133 |
| K963752 | Grace Medical, Inc. |
8624 NORTH LAKE COVE | ARLINGTON | TN | 38002 |
| K060518 | Grace Medical, Inc. |
8500 WOLF LAKE DR., STE. 110 | MEMPHIS | TN | 38133 |
| K972815 | Grace Medical, Inc. |
7715 HWY. 70, SUITE 109 | BARTLETT | TN | 38133 |
| K991394 | Grace Medical, Inc. |
7731 HWY. 70, SUITE 107 | BARTLETT | TN | 38133 |
| K000256 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K962564 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K033554 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K002464 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K003214 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K002737 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K000858 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K972492 | HEINZ KURZ |
TUEBINGER STRASSE 3 | DUSSLINGEN | D-72144 | |
| K973356 | HEINZ KURZ |
TUEBINGER STRASSE 3 | DUSSLINGEN | D-72144 | |
| K010442 | HEINZ KURZ |
AMSTEL 320-I | AMSTERDAM 1017AP | ||
| K990923 | HEINZ KURZ |
TUEBINGER STRASSE 3 | DUSSLINGEN | D-72144 | |
| K013573 | HEINZ KURZ GMBH MEDIZINTECHNIK |
AMSTEL 320-I | AMSTERDAM | 1017 AP | |
| K021479 | HEINZ KURZ GMBH MEDIZINTECHNIK |
AMSTEL 320-I | AMSTERDAM | 1017 AP | |
| K002221 | HEINZ KURZ GMBH MEDIZINTECHNIK |
AMSTEL 320-I | AMSTERDAM | 1017 AP | |
| K112616 | HEINZ KURZ GMBH MEDIZINTECHNIK |
AMSTEL 320-1 | AMSTERDAM | 1017 AP | |
| K130512 | HEINZ KURZ GMBH MEDIZINTECHNIK |
TUBINGER STRASSE 3 | DUSSLINGEN | D-72144 | |
| K992839 | HEINZ KURZ GMBH MEDIZINTECHNIK |
AMSTEL 320-I | AMSTERDAM | 1017 AP | |
| K241142 | Med-El Elektromedizinische GerΣte GmbH |
Fⁿrstenweg 77a | Innsbruck | 6020 | |
| K241261 | MED-EL Elektromedizinische GerΣte GmbH |
Fⁿrstenweg 77a | Innsbruck | 6020 | |
| K972737 | MEDNET LOCATOR, INC. |
7000 SHADOW OAKS | MEMPHIS | TN | 38125 |
| K972734 | MEDNET LOCATOR, INC. |
7000 SHADOW OAKS | MEMPHIS | TN | 38125 |
| K945105 | MICROMED DEVELOPMENT CORP. |
4911 CREEKSIDE DR. | CLEARWATER | FL | 34620 |
| K993234 | MICROMEDICS, INC. |
1285 CORPORATE CENTER DR., | EAGAN | MN | 55121 |
| K964909 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
| K002897 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
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