Submission Details
| 510(k) Number | K864824 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 09, 1986 |
| Decision Date | December 24, 1986 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K864824 is an FDA 510(k) clearance for the INFECTIOUS TISSUE KIT, submitted by American Scientific Products (Waukegan, US). The FDA issued a Cleared decision on December 24, 1986, 15 days after receiving the submission on December 9, 1986. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K864824 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 09, 1986 |
| Decision Date | December 24, 1986 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |