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 dialysate concentrate for hemodialysis (liquid or powder)
510(k) Number K982813
Device Name NATURALYTE, MODEL # 08-4004-1
Applicant
KAYBATH, INC.
95-547 UKEE STREET, #110
WAIPAHU,  HI  96797
Applicant Contact BONNIE NAKAYAMA
Correspondent
KAYBATH, INC.
95-547 UKEE STREET, #110
WAIPAHU,  HI  96797
Correspondent Contact BONNIE NAKAYAMA
Regulation Number876.5820
Classification Product Code
KPO  
Date Received08/11/1998
Decision Date 11/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-