K894778 is an FDA 510(k) clearance for the CODMAN RF-12 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 December 6, 1989, 132 days after receiving the submission on July 27, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4150.
| 510(k) Number | K894778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1989 |
| Decision Date | December 06, 1989 |
| Days to Decision | 132 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 |