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 Scaler, Ultrasonic
510(k) Number K853841
Device Name HARMO SONIC
Applicant
U.S. Shizai Corp.
12418 Santa Monica Blvd.
Los Angeles,  CA  90025
Applicant Contact TOM YOSHIDA
Correspondent
U.S. Shizai Corp.
12418 Santa Monica Blvd.
Los Angeles,  CA  90025
Correspondent Contact TOM YOSHIDA
Regulation Number872.4850
Classification Product Code
ELC  
Date Received09/16/1985
Decision Date 02/04/1986
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
-
-