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 Subsystem, Water Purification
510(k) Number K873487
Device Name HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES
Applicant
Water Pure, Inc.
11003 Bluegrass Pkwy.
Suite 600, Bldg. A
Louisville,  KY  40299
Applicant Contact RONALD L WATHEN
Correspondent
Water Pure, Inc.
11003 Bluegrass Pkwy.
Suite 600, Bldg. A
Louisville,  KY  40299
Correspondent Contact RONALD L WATHEN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received08/31/1987
Decision Date 10/23/1987
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
-
-