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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K813373
Device Name VYGON ENDOTRACHEAL TUBES
Applicant
Exco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Exco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5730
Classification Product Code
BTR  
Date Received12/01/1981
Decision Date 12/22/1981
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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