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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 (w/wo connector)
510(k) Number K781729
Device Name TRACHEOTOMY TUBES
Applicant
TRACOE MEDICAL GMBH
AM SCHLOSS, 20
D 6367 KARBEN 2,  DE
Correspondent
TRACOE MEDICAL GMBH
AM SCHLOSS, 20
D 6367 KARBEN 2,  DE
Regulation Number868.5800
Classification Product Code
BTO  
Date Received10/10/1978
Decision Date 10/24/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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