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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K043160
Device Name TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
Applicant
TRACOE MEDICAL GMBH
117 FLANDERS ROAD
WESTBOROUGH,  MA  01581
Applicant Contact MICHAEL A WARREN
Correspondent
TRACOE MEDICAL GMBH
117 FLANDERS ROAD
WESTBOROUGH,  MA  01581
Correspondent Contact MICHAEL A WARREN
Regulation Number868.5800
Classification Product Code
JOH  
Date Received11/15/2004
Decision Date 02/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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