K864405 is an FDA 510(k) clearance for the MANAN CONTRAST MEDIA ADMINISTRATION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Manan Manufacturing Co., Inc. (Skokie, US). The FDA issued a Cleared decision on December 18, 1986, 38 days after receiving the submission on November 10, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K864405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1986 |
| Decision Date | December 18, 1986 |
| Days to Decision | 38 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 |