K791910 is an FDA 510(k) clearance for the THREE LITER BAG #M-512. This device is classified as a Bag, Reservoir (Class I - General Controls, product code BTC).
Submitted by Mem Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 9, 1979, 14 days after receiving the submission on September 25, 1979.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5320.
| 510(k) Number | K791910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1979 |
| Decision Date | October 09, 1979 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTC — Bag, Reservoir |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5320 |