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
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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