K873688 is an FDA 510(k) clearance for the ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL. This device is classified as a Methyl Methacrylate For Aneurysmorrhaphy (Class II - Special Controls, product code JXH).
Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on October 26, 1987, 46 days after receiving the submission on September 10, 1987.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5030.
| 510(k) Number | K873688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1987 |
| Decision Date | October 26, 1987 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | JXH — Methyl Methacrylate For Aneurysmorrhaphy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5030 |