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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 K940448
Device Name NETOH ENDOTRACHEAL TUBE HOLDER
Applicant
MEDICAL ACCESSORY SERVICES, INC.
SUITE 109 - BOYKIN BUILDING
1704 11TH AVENUE SO.
BIRMINGHAM,  AL  35205
Applicant Contact MICHAEL SUDGE
Correspondent
MEDICAL ACCESSORY SERVICES, INC.
SUITE 109 - BOYKIN BUILDING
1704 11TH AVENUE SO.
BIRMINGHAM,  AL  35205
Correspondent Contact MICHAEL SUDGE
Regulation Number868.5770
Classification Product Code
CBH  
Date Received02/01/1994
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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