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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K925615
Device Name SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE
Applicant
Sorin Biomedica, Fiat, Usa, Inc.
17600 Gilette Ave.
Irvine,  CA  92713
Applicant Contact AMY BOUCLY
Correspondent
Sorin Biomedica, Fiat, Usa, Inc.
17600 Gilette Ave.
Irvine,  CA  92713
Correspondent Contact AMY BOUCLY
Regulation Number868.5740
Classification Product Code
CBI  
Date Received11/06/1992
Decision Date 03/26/1993
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
Recalls CDRH Recalls
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