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 K863166
Device Name MODEL 6110 IONTOPHORETIC APPLICATOR
Applicant
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Applicant Contact COATS, MD
Correspondent
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Correspondent Contact COATS, MD
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received08/18/1986
Decision Date 03/04/1987
Decision Substantially Equivalent (SESE)
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
-
-