K032393 is an FDA 510(k) clearance for the INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK). This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Elcam Medical Acal (Phoenix, US). The FDA issued a Cleared decision on September 12, 2003, 39 days after receiving the submission on August 4, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K032393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2003 |
| Decision Date | September 12, 2003 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMG — Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |