Submission Details
| 510(k) Number | K843813 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 1984 |
| Decision Date | December 05, 1984 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K843813 is an FDA 510(k) clearance for the INTRAVENOUS START KIT, submitted by Pro-Lab, Inc. (Round Rock, US). The FDA issued a Cleared decision on December 5, 1984, 68 days after receiving the submission on September 28, 1984. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K843813 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 1984 |
| Decision Date | December 05, 1984 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |