K841307 is an FDA 510(k) clearance for the BBL GASPAK POUCH. This device is classified as a Filter, Blood, Dialysis (Class II - Special Controls, product code FKJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on May 14, 1984, 45 days after receiving the submission on March 30, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K841307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1984 |
| Decision Date | May 14, 1984 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | FKJ — Filter, Blood, Dialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |