The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Dispos. Decannulation Plug W/sw/.
| Device ID | K843730 |
| 510k Number | K843730 |
| Device Name: | SHILEY DISPOS. DECANNULATION PLUG W/SW/ |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | SHILEY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-24 |
| Decision Date | 1984-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70884522005311 | K843730 | 000 |
| 70884522005274 | K843730 | 000 |
| 60884522005239 | K843730 | 000 |
| 70884522005199 | K843730 | 000 |
| 60884522004065 | K843730 | 000 |