K800825 is an FDA 510(k) clearance for the EXTENSION SET QUEST CODE #3000. This device is classified as a Tubing, Fluid Delivery (Class II - Special Controls, product code FPK).
Submitted by Quest Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1980, 30 days after receiving the submission on April 14, 1980.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K800825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1980 |
| Decision Date | May 14, 1980 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPK — Tubing, Fluid Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |