K843054 is an FDA 510(k) clearance for the DEKA SOLUTION ADMIN. SET DK 302-A. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Deka Research & Development Corp. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1984, 41 days after receiving the submission on August 3, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K843054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1984 |
| Decision Date | September 13, 1984 |
| Days to Decision | 41 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 |