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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 K172720
Device Name TRACOE silcosoft Tracheostomy Tube
Applicant
TRACOE medical GmbH
Reichelsheimer Str. 1/3
Nieder-Olm,  DE 55268
Applicant Contact Eva Schaeffer
Correspondent
Capamed Inc.
14 E.Eau Claire St. 447
Rice Lake,  WI  54868
Correspondent Contact Lu Anne Bauer
Regulation Number868.5800
Classification Product Code
JOH  
Date Received09/08/2017
Decision Date 04/27/2018
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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