• 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 Dialyzer Reprocessing System
510(k) Number K832705
Device Name ULTRAMAX
Applicant
Medicorp, Inc.
240 W. 2950 South
Salt Lake City,  UT  84115
Applicant Contact RICHARD K FIFE
Correspondent
Medicorp, Inc.
240 W. 2950 South
Salt Lake City,  UT  84115
Correspondent Contact RICHARD K FIFE
Regulation Number876.5820
Classification Product Code
LIF  
Date Received08/12/1983
Decision Date 06/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-