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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K770218
Device Name SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE
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 Number868.5800
Classification Product Code
BTO  
Date Received02/02/1977
Decision Date 02/09/1977
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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