K894050 is an FDA 510(k) clearance for the MODIFIED DECANNULATION STOPPER. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II - Special Controls, product code JOH).
Submitted by Premier Medical (Philadelphia, US). The FDA issued a Cleared decision on August 1, 1989, 55 days after receiving the submission on June 7, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K894050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1989 |
| Decision Date | August 01, 1989 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | JOH — Tube Tracheostomy And Tube Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |