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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 K950930
Device Name TRACHE-TITE
Applicant
The Varner Group, Inc.
601 Thirteenth St. NW
Washington,  DC  20005
Applicant Contact TERRY G MAHN
Correspondent
The Varner Group, Inc.
601 Thirteenth St. NW
Washington,  DC  20005
Correspondent Contact TERRY G MAHN
Regulation Number868.5770
Classification Product Code
CBH  
Date Received03/01/1995
Decision Date 03/22/1995
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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