K872782 is an FDA 510(k) clearance for the BBL(R) GASPAK CO2 POUCH(TM). This device is classified as a Device, Gas Generating (Class I - General Controls, product code KZJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on August 6, 1987, 23 days after receiving the submission on July 14, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2580.
| 510(k) Number | K872782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1987 |
| Decision Date | August 06, 1987 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | KZJ — Device, Gas Generating |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2580 |