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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 K100283
Device Name VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
Applicant
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact SUSANNE GALIN
Correspondent
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact SUSANNE GALIN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received02/01/2010
Decision Date 04/23/2010
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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