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FDA 510(k) Applications Submitted by TRACOE MEDICAL GMBH
FDA 510(k) Number
Submission Date
Device Name
Applicant
K172720
09/08/2017
TRACOE silcosoft Tracheostomy Tube
TRACOE medical GmbH
K961449
04/16/1996
TRACHEOSTOMY TUBES TRACOE-FLEX
TRACOE MEDICAL GMBH
K203362
11/16/2020
TRACOE vario
TRACOE medical GmbH
K051587
06/15/2005
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
TRACOE MEDICAL GMBH
K043160
11/15/2004
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
TRACOE MEDICAL GMBH
K152778
09/25/2015
TRACOE Cuff Pressure Monitor
TRACOE MEDICAL GMBH
K152865
09/30/2015
TRACOE smart Cuff Manager
TRACOE MEDICAL GMBH
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