K810292 is an FDA 510(k) clearance for the CAM-WRAP. This device is classified as a Light, Surgical, Accessories (Class II - Special Controls, product code FTA).
Submitted by Medline Industries, Inc. (Walker, US). The FDA issued a Cleared decision on March 4, 1981, 29 days after receiving the submission on February 3, 1981.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K810292 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1981 |
| Decision Date | March 04, 1981 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | FTA — Light, Surgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |