K880402 is an FDA 510(k) clearance for the CODMAN SURGICAL PATTIE. This device is classified as a Neurosurgical Paddie (Class II - Special Controls, product code HBA).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on March 2, 1988, 33 days after receiving the submission on January 29, 1988.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4700.
| 510(k) Number | K880402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1988 |
| Decision Date | March 02, 1988 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | HBA - Neurosurgical Paddie |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4700 |