K792033 is an FDA 510(k) clearance for the DYNACOR STERILE BLOOD GAS SPECIMEN TRAY. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1979, 37 days after receiving the submission on October 10, 1979.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K792033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1979 |
| Decision Date | November 16, 1979 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |