Submission Details
| 510(k) Number | K831936 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 15, 1983 |
| Decision Date | December 30, 1983 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K831936 is an FDA 510(k) clearance for the PRE-ROLLED TUBULAR STOCKINETTE, submitted by Ormed Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1983, 198 days after receiving the submission on June 15, 1983. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K831936 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 15, 1983 |
| Decision Date | December 30, 1983 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |