K782055 is an FDA 510(k) clearance for the CREAM, SIGNA. This device is classified as a Media, Electroconductive (Class II - Special Controls, product code GYB).
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 21, 1979, 100 days after receiving the submission on December 11, 1978.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1275.
| 510(k) Number | K782055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 1978 |
| Decision Date | March 21, 1979 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GYB — Media, Electroconductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1275 |