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, Iontophoresis, Other Uses
510(k) Number K894549
Device Name DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
Applicant
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Applicant Contact ERNEST J HENLEY,PHD
Correspondent
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Correspondent Contact ERNEST J HENLEY,PHD
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received07/20/1989
Decision Date 02/09/1990
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-