K871449 is an FDA 510(k) clearance for the ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Pa Medical Corp. (Columbia, US). The FDA issued a Cleared decision on June 17, 1987, 65 days after receiving the submission on April 13, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K871449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1987 |
| Decision Date | June 17, 1987 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KPE — Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |