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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 K843729
Device Name SHILEY DISPOS. CANNULA FENESTRATED LOW
Applicant
Shiley, Inc.
17600 Gillette Ave.
Irvine,  CA  92714 -
Applicant Contact KAREN SALINAS
Correspondent
Shiley, Inc.
17600 Gillette Ave.
Irvine,  CA  92714 -
Correspondent Contact KAREN SALINAS
Regulation Number868.5800
Classification Product Code
BTO  
Date Received09/24/1984
Decision Date 10/19/1984
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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