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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
Predetermined Change
Control Plan Authorized		 No
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