K830343 is an FDA 510(k) clearance for the CONTAINER W/PRIMING SOLUTION. This device is classified as a Regulator, Vacuum (Class II - Special Controls, product code KDP).
Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983, 44 days after receiving the submission on February 1, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K830343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1983 |
| Decision Date | March 17, 1983 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KDP — Regulator, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |