The following data is part of a premarket notification filed by Northern Electric Co. Div. Of Sunbeam Corp. with the FDA for Sunbeam Dental Care Center, Model No. 6273.
Device ID | K852593 |
510k Number | K852593 |
Device Name: | SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 |
Classification | Unit, Oral Irrigation |
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 | EFS |
CFR Regulation Number | 872.6510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-19 |
Decision Date | 1985-07-24 |