FDA 510(k) Applications for Medical Device:
Prosthesis, Esophageal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K060239 | ALVEOLUS, INC. |
9013 PERIMETER WOODS SUITE A | CHARLOTTE | NC | 28216 |
| K080838 | ALVEOLUS, INC. |
9013 PERIMETER WOODS DRIVE | CHARLOTTE | NC | 28216 |
| K051621 | ALVEOLUS, INC. |
9013 PERIMETER WOODS SUITE A | CHARLOTTE | NC | 28216 |
| K233939 | Boston Scientific |
300 Boston Scientific Way | Marlborough | MA | 01752 |
| K955347 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. | NATICK | MA | 01760-1537 |
| K032930 | BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PLACE | NATICK | MA | 01760-1537 |
| K012883 | BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place | Natick | MA | 01760 |
| K073266 | BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K211960 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K180144 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K233837 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K080332 | Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K091816 | Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K120983 | Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K130004 | Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K091510 | Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K002094 | C.R. BARD, INC. |
129 CONCORD RD., BLDG. #3 | BILLERICA | MA | 01821 |
| K093619 | COOK IRELAND LTD |
O'HALLORAN ROAD | LIMERICK | ||
| K080359 | COOK IRELAND LTD |
O'HALLORAN ROAD | LIMERICK | ||
| K162717 | Cook Ireland Ltd. |
O'Halloran Road, National Technology Park | Limerick | ||
| K092144 | ENDOCHOICE, INC. |
1914 J.N. PEASE PLACE | CHARLOTTE | NC | 28262 |
| K955041 | INSTENT, INC. |
6271 BURY DR. | EDEN PRAIRIE | MN | 55346 |
| K201160 | M.I. Tech Co., Ltd |
174, Habuk 2-gil, Jinwi-myeon | Pyeongtaek-si | 17706 | |
| K200860 | M.I. Tech Co., Ltd |
174, Habuk 2-gil, Jinwi-myeon | Pyeongtaek-si | 17706 | |
| K072094 | M.I. TECH CO., LTD. |
P.O. BOX 2007 | DEERFIELD | IL | 60015 |
| K093537 | M.I. TECH CO., LTD. |
49 CANDLEWOOD WAY | BUENA PARK | CA | 90621 |
| K213251 | M.I.Tech Co., Ltd. |
174, Habuk 2-gil, Jinwi-myeon | Pyeongtaek-si | 17706 | |
| K973584 | MEDTECH INSTRUMENTS |
6271 BURY DR. | EDEN PRAIRIE | MN | 55346 |
| K983297 | MEDTRONIC INSTENT, INC. |
6271 BURY DR. | EDEN PRAIRIE | MN | 55346 |
| K111611 | MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. | SOUTH JORDAN | UT | 84095-2415 |
| K251265 | Merit Medical Systems, Inc. |
1600 West Merit Parkway | South Jordan | UT | 84095 |
| K182910 | Micro-Tech (Nanjing) Co., Ltd. |
No. 10 Gaoke Third Road | Nanjing | 210032 | |
| K172813 | Micro-Tech (Nanjing) Co.,Ltd. |
No.10 Gaoke Third Road | Nanjing | 210032 | |
| K030559 | RUSCH INTL. |
50 PLANTATION DR. | JAFFERY | NH | 03452 |
| K010068 | RUSCH INTL. |
50 PLANTATION DR. | JAFFERY | NH | 03452 |
| K984068 | SCHNEIDER (EUROPE) GMBH |
ACKERSTRASSE 6 | BULACH | CH-8081 | |
| K240522 | Taewoong Medical |
14, Gojeong-ro | Gyeonggi-do | 10022 | |
| K123205 | TAEWOONG MEDICAL CO., LTD |
13417 QUIVAS ST | WESTMINSTER | CO | 80234 |
| K211706 | Taewoong Medical Co., Ltd |
14 Gojeong-ro, Wolgot-myeon | Gimpo-si | 10022 | |
| K113551 | TAEWOONG MEDICAL CO., LTD |
400 N. WASHINGTON ST | ALEXANDRIA | VA | 22314 |
| K080782 | TAEWOONG MEDICAL CO., LTD |
5536 TROWBRIDGE DRIVE | DUNWOODY | GA | 30338 |
| K041648 | TAEWOONG MEDICAL CO., LTD |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K221482 | Taewoong Medical Co., Ltd. |
14 Gojeong-Ro, Wolgot-Myeon | Gimpo-Si | 10022 | |
| K223266 | Thoracent, Inc. |
120 New York Ave | Huntington | NY | 11743 |
| K003173 | VASCULAR ARCHITECTS, INC. |
1830 BERING DR. | SAN JOSE | CA | 95112-4226 |
| K011591 | WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. | WINSTON-SALEM | NC | 27105 |
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