Submission Details
| 510(k) Number | K850246 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 22, 1985 |
| Decision Date | April 09, 1985 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K850246 is an FDA 510(k) clearance for the MASTER KIT A, submitted by Pro-Lab, Inc. (Birmingham, US). The FDA issued a Cleared decision on April 9, 1985, 77 days after receiving the submission on January 22, 1985. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K850246 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 22, 1985 |
| Decision Date | April 09, 1985 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |