K934119 is an FDA 510(k) clearance for the ENERGIZED DRUG CONTAINER SYSTEM. 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 June 9, 1994, 288 days after receiving the submission on August 25, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K934119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1993 |
| Decision Date | June 09, 1994 |
| Days to Decision | 288 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 |