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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 And Tube Cuff
510(k) Number K903435
Device Name SHILEY SPECIALIZED TRACHEOSTOMY TUBE
Applicant
SHILEY, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92714
Applicant Contact ALLAN L ABATI
Correspondent
SHILEY, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92714
Correspondent Contact ALLAN L ABATI
Regulation Number868.5800
Classification Product Code
JOH  
Date Received07/31/1990
Decision Date 10/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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