Submission Details
| 510(k) Number | K791634 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1979 |
| Decision Date | September 17, 1979 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K791634 is an FDA 510(k) clearance for the AO STYLET LARYNGOSCOPE, MODEL SLS-1, a Laryngoscope, Non-rigid (Class I — General Controls, product code CAL), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979, 27 days after receiving the submission on August 21, 1979. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5530.
| 510(k) Number | K791634 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1979 |
| Decision Date | September 17, 1979 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAL — Laryngoscope, Non-rigid |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5530 |