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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cuff, tracheal tube, inflatable
510(k) Number K792265
Device Name SHILEY PRESSURE RELIEF ADAPTER PRA
Applicant
SHILEY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SHILEY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5750
Classification Product Code
BSK  
Date Received11/09/1979
Decision Date 11/27/1979
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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