K761097 is an FDA 510(k) clearance for the VANDERBILT BLADE HOLDER. This device is classified as a Instrument, Surgical, Non-powered (Class I - General Controls, product code HAO).
Submitted by Codman & Shurtleff, Inc. (Walker, US). The FDA issued a Cleared decision on November 30, 1976, 8 days after receiving the submission on November 22, 1976.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4535.
| 510(k) Number | K761097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1976 |
| Decision Date | November 30, 1976 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | HAO - Instrument, Surgical, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.4535 |