Home / 510(k) Clearances / K925615

510(k) K925615

SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE by Sorin Biomedica, Fiat, USA, Inc. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1993
Date Received
November 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5740
Review Panel
AN
Submission Type

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