K904352 is an FDA 510(k) clearance for the CODMAN COLLINS RADIOPARENT STERNAL BLADES. This device is classified as a Blade, Saw, Surgical, Cardiovascular (Class I - General Controls, product code DWH).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on November 21, 1990, 58 days after receiving the submission on September 24, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K904352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1990 |
| Decision Date | November 21, 1990 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | DWH - Blade, Saw, Surgical, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |