K911917 is an FDA 510(k) clearance for the CODMAN PEDIATRIC HORSESHOE HEADREST. This device is classified as a Headrest, Neurosurgical (Class I - General Controls, product code HBM).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on July 17, 1991, 78 days after receiving the submission on April 30, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4440.
| 510(k) Number | K911917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1991 |
| Decision Date | July 17, 1991 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HBM - Headrest, Neurosurgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.4440 |