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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 K955461
Device Name TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
Applicant
VBM Medizintechnik GmbH
6072 S. 2550 W.
Roy,  UT  84067 -3211
Applicant Contact R. DOUGLAS JACOB
Correspondent
VBM Medizintechnik GmbH
6072 S. 2550 W.
Roy,  UT  84067 -3211
Correspondent Contact R. DOUGLAS JACOB
Regulation Number868.5800
Classification Product Code
BTO  
Date Received11/29/1995
Decision Date 03/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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