K150532 is an FDA 510(k) clearance for the Universal Light Handle Cover, Light Handle Cover. This device is classified as a Light, Surgical, Accessories (Class II - Special Controls, product code FTA).
Submitted by Key Surgical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 22, 2015, 204 days after receiving the submission on March 2, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K150532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2015 |
| Decision Date | September 22, 2015 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTA — Light, Surgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |