K802138 is an FDA 510(k) clearance for the CHEEK TOOL SET. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980, 57 days after receiving the submission on September 4, 1980.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K802138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1980 |
| Decision Date | October 31, 1980 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | GWM - Device, Monitoring, Intracranial Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1620 |