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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 K864526
Device Name ENDOTRACHEAL TUBE HOLDER
Applicant
Mathew Medical Co.
2346 E. Orangewood Ave.
Phoenix,  AZ  85020
Applicant Contact KENNETH R BOWERS,JR
Correspondent
Mathew Medical Co.
2346 E. Orangewood Ave.
Phoenix,  AZ  85020
Correspondent Contact KENNETH R BOWERS,JR
Regulation Number868.5770
Classification Product Code
CBH  
Date Received11/17/1986
Decision Date 05/21/1987
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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