K791764 is an FDA 510(k) clearance for the SCOVILLE-LEWIS ANEURYSM CLIPS. This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1979, 34 days after receiving the submission on August 28, 1979.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.
| 510(k) Number | K791764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1979 |
| Decision Date | October 01, 1979 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | HCH - Clip, Aneurysm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5200 |