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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 K880247
Device Name MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
Applicant
SHILEY, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92714
Applicant Contact GANZ POBUDA
Correspondent
SHILEY, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92714
Correspondent Contact GANZ POBUDA
Regulation Number868.5800
Classification Product Code
BTO  
Date Received01/20/1988
Decision Date 02/12/1988
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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