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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 K942529
Device Name HCI TUBE STABILIZER
Applicant
Health Care Contracts, Inc.
5405 Bandere Rd.
Suite 116
San Antonio,  TX  78238
Applicant Contact DEAN WENRICH
Correspondent
Health Care Contracts, Inc.
5405 Bandere Rd.
Suite 116
San Antonio,  TX  78238
Correspondent Contact DEAN WENRICH
Regulation Number868.5770
Classification Product Code
CBH  
Date Received05/27/1994
Decision Date 06/14/1995
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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