Submission Details
| 510(k) Number | K894755 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 27, 1989 |
| Decision Date | January 12, 1990 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K894755 is an FDA 510(k) clearance for the ASTRA DISPOSABLE SPRAY CANNULA, a Applicator (laryngo-tracheal), Topical Anesthesia (Class II — Special Controls, product code CCT), submitted by Astra Pharmaceutical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on January 12, 1990, 169 days after receiving the submission on July 27, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5170.
| 510(k) Number | K894755 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 27, 1989 |
| Decision Date | January 12, 1990 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCT — Applicator (laryngo-tracheal), Topical Anesthesia |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5170 |