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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Support, Breathing Tube
510(k) Number K833361
Device Name TUBE-TITLE
Applicant
SONTEK INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SONTEK INDUSTRIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5280
Classification Product Code
JAY  
Date Received09/27/1983
Decision Date 11/03/1983
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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