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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 K051587
Device Name TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
Applicant
Tracoe Medical GmbH
117 Flanders Rd.
Westborough,  MA  01581
Applicant Contact MICHAEL A WARREN
Correspondent
Tracoe Medical GmbH
117 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact MICHAEL A WARREN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/15/2005
Decision Date 10/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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