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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 SOUTH 2550 WEST
ROY,  UT  84067 -3211
Applicant Contact R. DOUGLAS JACOB
Correspondent
VBM MEDIZINTECHNIK GMBH
6072 SOUTH 2550 WEST
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
Recalls CDRH Recalls
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