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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 K884730
Device Name SHILEY PERC TRACHEOSTOMY SYSTEM
Applicant
SHILEY, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92714
Applicant Contact MERRITT M GIRGIS
Correspondent
SHILEY, INC.
17600 GILLETTE AVE.
P.O. BOX 19503
IRVINE,  CA  92714
Correspondent Contact MERRITT M GIRGIS
Regulation Number868.5800
Classification Product Code
BTO  
Date Received11/10/1988
Decision Date 01/17/1989
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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