K071776 is an FDA 510(k) clearance for the ANEUROPLASTIC, MODEL 43-1290. This device is classified as a Methyl Methacrylate For Aneurysmorrhaphy (Class II - Special Controls, product code JXH).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on July 26, 2007, 27 days after receiving the submission on June 29, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5030.
| 510(k) Number | K071776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2007 |
| Decision Date | July 26, 2007 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXH - Methyl Methacrylate For Aneurysmorrhaphy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5030 |