FDA 510(k) Applications for Medical Device:
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K203749 | Ambu A/S |
Baltorpbakken 13 | Ballerup | 2750 | |
| K160542 | COOK INCORPORATED |
750 DANIELS WAY | BLOOMINGTON | IN | 47404 |
| K021920 | COOK, INC. |
P.O. BOX 489 | BLOOMINGTON | IN | 47402-0489 |
| K002288 | COOK, INC. |
925 SOUTH CURRY PIKE | BLOOMINGTON | IN | 47402 |
| K962167 | COOK, INC. |
P.O. BOX 489 | BLOOMINGTON | IN | 47402 |
| K013865 | COOK, INC. |
925 SOUTH CURRY PIKE | BLOOMINGTON | IN | 47402 |
| K093888 | DAIKEN MEDICAL CO, LTD. |
4-1-17 HONGO, BUNKYO-KU | TOKYO | 113-0033 | |
| K071694 | DAIKEN MEDICAL CO, LTD. |
4-2-1 YUSHIMA, BUNKYO-KU | TOKYO | 113-0034 | |
| K113576 | ETVIEW LTD. |
31 HAAVODA ST. | BINYAMINA | 30500 | |
| K120334 | ETVIEW LTD. |
31 HAAVODA ST. | BINYAMINA | 30500 | |
| K123853 | ETVIEW LTD. |
31 HAAVODA ST. | BINYAMINA | 30500 | |
| K181886 | ETView Ltd. |
M.P Misgav | Misgav Business Park | 2017900 | |
| K121462 | EZ-BLOCKER B.V. |
4655 KIRKWOOD COURT | BOULDER | CO | 80301 |
| K051522 | FUJI SYSTEMS CORP. |
6329 W. WATERVIEW COURT | MCCORDSVILLE | IN | 46055-9501 |
| K152251 | HENAN TUOREN MEDICAL DEVICE CO., LTD |
WEIYUAN INDUSTRIAL ZONE, MENGGANG, CHANGYUAN COUNTRY | XINXIANG | 453400 | |
| K201026 | HyTek Medical, Inc. |
8741 Shirley Ave | Northridge | CA | 91324 |
| K200968 | INSUNG MEDICAL CO., LTD. |
168, Gieopdosi-Ro, Jijeong-Myeon, Wonju-Si | Gangwon-Do | 26354 | |
| K961977 | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K222340 | Pulmonx Corporation |
700 Chesapeake Road | Redwood City | CA | 94063 |
| K083883 | PULMONX, INC. |
24125 85TH AVE SE | WOODINVILLE | WA | 98272 |
| K111522 | PULMONX, INC. |
700 CHESAPEAKE DRIVE | REDWOOD CITY | CA | 94063 |
| K010596 | RUSCH INTL. |
50 PLANTATION DR. | JAFFERY | NH | 03452 |
| K232529 | Shenzhen Insighters Medical Technology Co., Ltd. |
The 13th floor of Hengtemei Building Ganli Road No.3 | Shenzhen | 518000 | |
| K232580 | Shenzhen Insighters Medical Technology Co., Ltd. |
The 13th floor of Hengtemei Building Ganli Road No.3 | Shenzhen | 518000 | |
| K180253 | Teleflex Medical |
3015 Carrington Mills Blvd | Morrisville | NC | 27560 |
| K141888 | Teleflex Medical, Inc. |
2917 WECK DR. | RESEARCH TRIANGLE PARK | NC | 27709 |
| K092886 | WELL LEAD INSTRUMENTS |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33570 |
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