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 Device, Electrical Dental Anesthesia
510(k) Number K902948
Device Name COMFORTRON II (TENS)
Applicant
M. D. Products
2137 SE Fort King
Ocala,  FL  32671
Applicant Contact DREYFUS, DDS
Correspondent
M. D. Products
2137 SE Fort King
Ocala,  FL  32671
Correspondent Contact DREYFUS, DDS
Classification Product Code
LWM  
Date Received07/05/1990
Decision Date 12/17/1990
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-