The following data is part of a premarket notification filed by Sunbeam Corp. with the FDA for Massager, Gum/ssage Powered Gum.
| Device ID | K780360 |
| 510k Number | K780360 |
| Device Name: | MASSAGER, GUM/SSAGE POWERED GUM |
| Classification | Toothbrush, Powered |
| Applicant | SUNBEAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-06 |
| Decision Date | 1978-05-26 |