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 K896444
Device Name IONTOPHORESIS DEVICE - ELECTRODE RH 800
Applicant
Iomed, Inc.
2471 E. Shadow Wood Cir.
P.O. Box 17801
Salt Lake City,  UT  84117
Applicant Contact DONALD F GRABARZ
Correspondent
Iomed, Inc.
2471 E. Shadow Wood Cir.
P.O. Box 17801
Salt Lake City,  UT  84117
Correspondent Contact DONALD F GRABARZ
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received11/09/1989
Decision Date 05/10/1990
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 Yes
Predetermined Change
Control Plan Authorized		 No
-
-