The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Cream, Signa.
| Device ID | K782055 |
| 510k Number | K782055 |
| Device Name: | CREAM, SIGNA |
| Classification | Media, Electroconductive |
| Applicant | PARKER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-11 |
| Decision Date | 1979-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20855683006245 | K782055 | 000 |
| 10855683006859 | K782055 | 000 |