The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Specialized Tracheostomy Tube.
| Device ID | K903435 |
| 510k Number | K903435 |
| Device Name: | SHILEY SPECIALIZED TRACHEOSTOMY TUBE |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Allan L Abati |
| Correspondent | Allan L Abati SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-10-02 |