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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 K851874
Device Name OR TUBE RESTRAINT
Applicant
KINETIC CONCEPTS, INC.
4958 STOUT DR.
SAN ANTONIO,  TX  78219
Applicant Contact ROBERT A NEHRMEYER
Correspondent
KINETIC CONCEPTS, INC.
4958 STOUT DR.
SAN ANTONIO,  TX  78219
Correspondent Contact ROBERT A NEHRMEYER
Regulation Number868.5770
Classification Product Code
CBH  
Date Received04/29/1985
Decision Date 08/08/1985
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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