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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Airway (Extension)
510(k) Number K813383
Device Name DISPOSABLE TRACH SWIVEL CONNECTOR
Applicant
INTEC.
22200 East 40 Highway
Blue Springs,  MO  64015
Applicant Contact J.W. Brown
Correspondent
INTEC.
22200 East 40 Highway
Blue Springs,  MO  64015
Correspondent Contact J.W. Brown
Regulation Number868.5810
Classification Product Code
BZA  
Date Received12/02/1981
Decision Date 12/31/1981
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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