Submission Details
| 510(k) Number | K132276 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 2013 |
| Decision Date | November 12, 2013 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
K132276 is an FDA 510(k) clearance for the STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML, a Container, I.v. (Class II — Special Controls, product code KPE), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on November 12, 2013, 113 days after receiving the submission on July 22, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K132276 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 2013 |
| Decision Date | November 12, 2013 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE — Container, I.v. |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5025 |