K954283 is an FDA 510(k) clearance for the ENERGIZED CONTAINER SYSTEM (MODIFICATION). This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 29, 1996, 267 days after receiving the submission on September 5, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K954283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1995 |
| Decision Date | May 29, 1996 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |