K962581 is an FDA 510(k) clearance for the STOPCOCK MANIFOLD GANGS. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on August 28, 1996, 58 days after receiving the submission on July 1, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K962581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1996 |
| Decision Date | August 28, 1996 |
| Days to Decision | 58 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 |