K905433 is an FDA 510(k) clearance for the CODMAN DISPOSABLE SCALP CLIP APPLIER. This device is classified as a Clip, Scalp (Class II - Special Controls, product code HBO).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on February 21, 1991, 79 days after receiving the submission on December 4, 1990.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4150.
| 510(k) Number | K905433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1990 |
| Decision Date | February 21, 1991 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HBO — Clip, Scalp |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4150 |