The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Perc Tracheostomy System.
| Device ID | K884730 |
| 510k Number | K884730 |
| Device Name: | SHILEY PERC TRACHEOSTOMY SYSTEM |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Merritt M Girgis |
| Correspondent | Merritt M Girgis SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-10 |
| Decision Date | 1989-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50884522006703 | K884730 | 000 |
| 40884522006683 | K884730 | 000 |