The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Sleep Apnea Cuffless Fenestrated Trach Tube.
| Device ID | K861461 |
| 510k Number | K861461 |
| Device Name: | SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Morton Barak |
| Correspondent | Morton Barak SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-21 |
| Decision Date | 1986-05-06 |