Shiley, Inc. · Class II · Cleared Mar 9, 1984
| K-number | K840539 |
| Device name | DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY |
| Applicant | Shiley, Inc. |
| Product code | BTO |
| Device class | Class II |
| Decision date | Mar 9, 1984 |
| Decision | Substantially Equivalent |
| Regulation | 868.5800 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov