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 |
| K243655 | Spirair, Inc |
415 Grand Avenue, Suite 201 | South San Francisco | CA | 94080 |
| 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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