K800664 is an FDA 510(k) clearance for the SURE FLOW TUBING. This device is classified as a Tubing, Pressure And Accessories (Class I - General Controls, product code BYX).
Submitted by B & F Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1980, 7 days after receiving the submission on March 26, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5860.
| 510(k) Number | K800664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1980 |
| Decision Date | April 02, 1980 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYX — Tubing, Pressure And Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5860 |