K827296 is an FDA 510(k) clearance for the POLYSONIC ULTRASOUND LOTION. This device is classified as a Media, Coupling, Ultrasound (Class II - Special Controls, product code MUI).
Submitted by Parker Laboratories, Inc. (Orange, US). The FDA issued a Cleared decision on April 16, 1982, 17 days after receiving the submission on March 30, 1982.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K827296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1982 |
| Decision Date | April 16, 1982 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | MUI — Media, Coupling, Ultrasound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |