FDA 510(k) Applications for Medical Device:
Splint, Intranasal Septal
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K140992 |
ARTHROCARE CORPORATION |
7000 West William Cannon Drive
| Austin |
TX |
78735 |
K230142 |
BioMed ENT, Inc. |
18911 Hardy Oak Blvd
| San Antonio |
TX |
78258 |
K972096 |
BOSTON MEDICAL PRODUCTS, INC. |
117 FLANDERS RD.
| WESTBOROUGH |
MA |
01581 |
K972082 |
BOSTON MEDICAL PRODUCTS, INC. |
117 FLANDERS RD.
| WESTBOROUGH |
MA |
01581 |
K972151 |
BOSTON MEDICAL PRODUCTS, INC. |
117 FLANDERS RD.
| WESTBOROUGH |
MA |
01581 |
K972092 |
BOSTON MEDICAL PRODUCTS, INC. |
117 FLANDERS RD.
| WESTBOROUGH |
MA |
01581 |
K070496 |
CARBYLAN BIOSURGERY |
3181 PORTER DRIVE
| PALO ALTO |
CA |
94304 |
K063308 |
CARBYLAN BIOSURGERY |
3181 PORTER DRIVE
| PALO ALTO |
CA |
94304 |
K172179 |
Chitogel Ltd |
139 Moray Place
| Dunedin |
|
9016 |
K113585 |
COGENT THERAPEUTICS, LLC |
3637 BERNAL AVENUE
| PLEASANTON |
CA |
94566 |
K130354 |
ENTRIGUE SURGICAL, INC. |
12672 SILICON DR. STE 150
| SAN ANTONIO |
TX |
78249 |
K012532 |
GENZYME CORP. |
1125 PLEASANT VIEW TERRANCE
| RIDGEFIELD |
NJ |
07657 |
K181696 |
Gyrus ACMI, Inc |
136 Turnpike Road
| Southborough |
MA |
01772 |
K122494 |
HEMOSTASIS, LLC |
5000 Township Pkwy
| Saint Paul |
MN |
55110 |
K141704 |
MEDTRONIC INC. |
6743 SOUTHPOINT DRIVE NORTH
| JACKSONVILLE |
FL |
32259 |
K202623 |
Medtronic Xomed |
6743 Southpoint Drive North
| Jacksonville |
FL |
32256 |
K041381 |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH
| JACKSONVILLE |
FL |
32216 |
K141816 |
Polyganics BV |
ROZENBURGLAAN 15A
| GRONINGEN |
|
9727DL |
K052099 |
Polyganics BV |
L.J. ZIELSTRAWEG 1
| GRONINGEN |
|
9713-GX |
K141423 |
Polyganics BV |
ROZENBURGLAAN 15A
| GRONINGEN |
|
9727-DL |
K981374 |
POREX SURGICAL, INC. |
4715 ROOSEVELT HWY.
| COLLEGE PARK |
GA |
30349-2417 |
K011544 |
SEIKAGAKU CORP. |
90 POTESKEET TRAIL
| KITTY HAWK |
NC |
27949 |
K980221 |
SILIMED, LLC. |
P.O BOX 4341
| CROFTON |
MD |
21114 |
K092401 |
SINEXUS, INC. |
1049 ELWELL CT.
| PALO ALTO |
CA |
94303 |
K132721 |
SPIWAY LLC |
1046 LA MIRADA ST.
| LAGUNA BEACH |
CA |
92651 |
K153686 |
SPIWAY LLC |
1120 CALLE CORDILLERA, #102
| SAN CLEMENTE |
CA |
92673 |
K180141 |
SPIWay, LLC |
3600 Corte Castillo
| Carlsbad |
CA |
92009 |
K213153 |
SPIWay, LLC |
3600 Corte Castillo
| Carlsbad |
CA |
92009 |
K170913 |
STS Medical |
37 Amal
| Petah Tikva |
|
4951337 |
K082276 |
SYNTHEMED, INC. |
200 MIDDLESEX ESSEX TPK.
| ISELIN |
NJ |
08830 |
K002131 |
WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR.
| JACKSONVILLE |
FL |
32218 |
K080247 |
Z-MEDICA CORPORATION |
4 FAIRFIELD BLVD.
| WALLINGFORD |
CT |
06492 |
|
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