The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Shiley Specialized,pediatric & Neonatal Trach.tube.
Device ID | K925615 |
510k Number | K925615 |
Device Name: | SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE |
Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
Applicant | SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine, CA 92713 |
Contact | Amy Boucly |
Correspondent | Amy Boucly SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine, CA 92713 |
Product Code | CBI |
CFR Regulation Number | 868.5740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-06 |
Decision Date | 1993-03-26 |