FDA 510(k) Applications for Medical Device:
Cuff, Tracheal Tube, Inflatable
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K092733 | ARM MEDICAL DEVICES, INC. |
190 DINO ROAD | BRISTOL | CT | 06010-7888 |
| K220854 | AW Technologies ApS |
Amalienborgvej 57 | Noerresundby | DK-9700 | |
| K192611 | Biovo Technologies Ltd. |
23 HaMelacha St | ROsh HaAyin | 4809173 | |
| K202874 | Covidien llc |
6F, Building 3, 2388 Chenhang Road | Shanghai | 201114 | |
| K150893 | HAMILTON MEDICAL AG |
VIA CRUSCH 8 | BONADUZ | 7402 | |
| K180991 | Hospitech Respiration Ltd. |
20 Hamagshimim St. Kiryat Matalon | Petach Tikva | 49348 | |
| K122721 | HOSPITECH RESPIRATION LTD. |
31 HAAVODA ST | BINYAMINA | 30500 | |
| K221477 | Hospitech Respiration Ltd. |
15 Atir Yeda | Kfar Saba | 446312 | |
| K150157 | HOSPITECH RESPIRATION LTD. |
20 HAMAGSHIMIM ST. KIRYAT MATALON | PETACH TIKVA | 49348 | |
| K113644 | INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. | BETHEL PARK | PA | 15102 |
| K973755 | INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. | BETHEL PARK | PA | 15102 |
| K102704 | JOAN SPIEGEL, MD |
24301 | BONITA SPRINGS | FL | 34134 |
| K191858 | Kal-Med LLC |
570 Percival Avenue | Kensington | CT | 06037 |
| K112915 | SPIRITUS TECHNOLOGIES LLC |
12005 W. 100TH TERRACE | LENEXA | KS | 66215 |
| K081805 | SUNMED |
24301 WOODSAGE DR. | BONITA SPRINGS | FL | 34134-2958 |
| K142103 | Teleflex Medical, Inc. |
3015 Carrington Mill Blvd | Morrisville | NC | 27560 |
| K182548 | Tianjin Medis Medical Device Co., Ltd. |
No. 15-A, Saida One Avenue, Xiqing Economic Development Area | Tainjin | 300385 | |
| K152778 | TRACOE MEDICAL GMBH |
REICHELSHEIMER STR. 1/3 | NIEDER-OLM | D-55268 | |
| K152865 | TRACOE MEDICAL GMBH |
REICHELSHEIMER STR. 1/3 | NIEDER-OLM | D-55268 | |
| K110631 | VENNER MEDICAL (SINGAPORE) PTE LTD |
7 Trail House Court | Rockville | MD | 20850 |
| K102674 | VENTLAB CORP. |
155 BOYCE DRIVE | MOCKSVILLE | NC | 27028 |
| K173914 | VORTRAN Medical Technology 1, Inc. |
21 Goldenland Court | Sacramento | CA | 95834 |
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