Submission Details
| 510(k) Number | K802663 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 28, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K802663 is an FDA 510(k) clearance for the BLOW-BY-SET-UP CONNECTOR-AIRWAY, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980, 15 days after receiving the submission on October 28, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.
| 510(k) Number | K802663 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 28, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZA — Connector, Airway (extension) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5810 |