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 system, dialysate delivery, central multiple patient
510(k) Number K834587
Device Name HEMODIAL CONCENTRATE
Applicant
MOANA PRODUCTIONS, INC.
1190 EAST 5425 SOUTH
OGDEN,  UT  84403 -
Applicant Contact LETANE M FONOTI
Correspondent
MOANA PRODUCTIONS, INC.
1190 EAST 5425 SOUTH
OGDEN,  UT  84403 -
Correspondent Contact LETANE M FONOTI
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received12/29/1983
Decision Date 04/13/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-