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 |