The following data is part of a premarket notification filed by Northern Electric Co. Div. Of Sunbeam Corp. with the FDA for Sunbeam Ultrasonic Denture Cleaner Model 4220.
| Device ID | K860118 |
| 510k Number | K860118 |
| Device Name: | SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 |
| Classification | Cleanser, Denture, Over The Counter |
| Applicant | NORTHERN ELECTRIC CO. DIV. OF SUNBEAM CORP. 5224 NORTH KEDZIE Chicago, IL 60625 |
| Contact | Scheck |
| Correspondent | Scheck NORTHERN ELECTRIC CO. DIV. OF SUNBEAM CORP. 5224 NORTH KEDZIE Chicago, IL 60625 |
| Product Code | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-13 |
| Decision Date | 1986-04-17 |