Submission Details
| 510(k) Number | K790931 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 15, 1979 |
| Decision Date | May 21, 1979 |
| Days to Decision | 6 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K790931 is an FDA 510(k) clearance for the CORRUGATED TUBE WITH MOUTHPIECE. This device is classified as a Mouthpiece, Breathing (Class I — General Controls, product code BYP).
Submitted by Mem Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1979, 6 days after receiving the submission on May 15, 1979.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5620.
| 510(k) Number | K790931 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 15, 1979 |
| Decision Date | May 21, 1979 |
| Days to Decision | 6 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYP — Mouthpiece, Breathing |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5620 |