The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Elbow 15mm Swivel Connector.
| Device ID | K895388 |
| 510k Number | K895388 |
| Device Name: | SHILEY ELBOW 15MM SWIVEL CONNECTOR |
| Classification | Connector, Airway (extension) |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | David Taylor |
| Correspondent | David Taylor SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-30 |
| Decision Date | 1989-10-27 |