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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Tracheal Tube
510(k) Number K941384
Device Name TRAKEEZ
Applicant
Ergomed, Inc.
5426 Billington Dr.
San Antonio,  TX  78230
Applicant Contact J.T. BOWLIN
Correspondent
Ergomed, Inc.
5426 Billington Dr.
San Antonio,  TX  78230
Correspondent Contact J.T. BOWLIN
Regulation Number868.5770
Classification Product Code
CBH  
Date Received03/22/1994
Decision Date 04/19/1994
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
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