K841361 is an FDA 510(k) clearance for the SYRINGE ADDITIVE IV ADMIN. SETS. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Quest Medical, Inc. (Walker, US). The FDA issued a Cleared decision on May 21, 1984, 49 days after receiving the submission on April 2, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K841361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1984 |
| Decision Date | May 21, 1984 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |