Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Cleanser, Denture, Over The Counter
510(k) Number K860118
Device Name SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220
Applicant
Northern Electric Co. Div. of Sunbeam Corp.
5224 N. Kedzie
Chicago,  IL  60625
Applicant Contact SCHECK
Correspondent
Northern Electric Co. Div. of Sunbeam Corp.
5224 N. Kedzie
Chicago,  IL  60625
Correspondent Contact SCHECK
Regulation Number872.3520
Classification Product Code
EFT  
Date Received01/13/1986
Decision Date 04/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-