K955721 is an FDA 510(k) clearance for the CUFFED OROPHARYNGEAL AIRWAY (COPA). This device is classified as a Airway, Oropharyngeal, Anesthesiology (Class I - General Controls, product code CAE).
Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on March 28, 1997, 466 days after receiving the submission on December 18, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5110.
| 510(k) Number | K955721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1995 |
| Decision Date | March 28, 1997 |
| Days to Decision | 466 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAE — Airway, Oropharyngeal, Anesthesiology |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5110 |