The following data is part of a premarket notification filed by Northern Electric Co. Div. Of Sunbeam Corp. with the FDA for Sunbeam Rechargeable Toothbrush Model # 4201.
Device ID | K852279 |
510k Number | K852279 |
Device Name: | SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201 |
Classification | Toothbrush, Powered |
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 | JEQ |
CFR Regulation Number | 872.6865 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-29 |
Decision Date | 1985-07-01 |