FDA 510(k) Applications for Medical Device:
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K013243 | BIOFORM, INC. |
4133 COURTNEY ROAD, #10 | FRANKSVILLE | WI | 53126 |
| K060561 | CAMBRIDGEMED |
800 WEST CUMMINGS PARK | WOBURN | MA | 01801 |
| K070093 | CEREMED INC. |
3643 LENAWEE AVE. | LOS ANGELES | CA | 90016 |
| K122561 | CEREMED, INC. |
3643 LENAWEE AVE. | LOS ANGELES | CA | 90016 |
| K120220 | CEREMED, INC. |
3643 LENAWEE AVE. | LOS ANGELES | CA | 90016 |
| K132198 | CEREMED, INC. |
3643 LENAWEE AVE. | LOS ANGELES | CA | 90016 |
| K081531 | CEREMED, INC. |
3643 LENAWEE AVE. | LOS ANGELES | CA | 90016 |
| K082245 | CEREMED, INC. |
3643 LENAWEE AVE. | LOS ANGELES | CA | 90016 |
| K103047 | CEREMED, INC. |
3643 LENAWEE AVE. | LOS ANGELES | CA | 90016 |
| K062280 | CEREMED, INC. |
3643 LENAWEE AVE. | LOS ANGELES | CA | 90016 |
| K161000 | COOK BIOTECH INCORPORATED |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47909 |
| K121360 | COOK BIOTECH INCORPRATED |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906-1000 |
| K150594 | COOK BIOTECH INCORPRATED |
1425 INNOVATION PLACE | WEST LAFAYETTE | IN | 47906 |
| K051911 | CURAMEDICAL, BV |
220 RIVER ROAD | CLAREMONT | NH | 03743 |
| K060878 | CURAMEDICAL, BV |
220 RIVER ROAD | CLAREMONT | NH | 03743 |
| K051487 | DOCTOR'S RESEARCH GROUP, INC. |
50 ALTAIR AVE. | PLYMOUTH | CT | 06782 |
| K972700 | EXMOOR PLASTICS LTD. |
LISIEUX WAY | TAUNTON, SOMERSET | TA1 2LB | |
| K003855 | FIDIA ADVANCED BIOPOLYMERS SRL |
VIA PONTE DELLA FABBRICA,3/A | 35031 ABANO TERME (PD) | 35031 | |
| K043035 | GENZYME CORPORATION |
55 CAMBRIDGE PARKWAY | CAMBRIDGE | MA | 02142 |
| K974311 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K991324 | HEINZ KURZ |
TUEBINGER STRASSE 3 | DUSSLINGEN | D-72144 | |
| K033796 | HEINZ KURZ GMBH MEDIZINTECHNIK |
AMSTEL 320-I | AMSTERDAM | 1017 AP | |
| K002972 | MEDTRONIC XOMED |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K080022 | VASCULAR SOLUTIONS, INC. |
6464 Sycamore Court North | Minneapolis | MN | 55369 |
| K982870 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
| K964484 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
| K001148 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
| K970910 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
| K982294 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
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