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 K893991
Device Name HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
Applicant
P & A Co.
P.O. Box 10376
Santa Ana,  CA  92711
Applicant Contact ROBERT ABELS
Correspondent
P & A Co.
P.O. Box 10376
Santa Ana,  CA  92711
Correspondent Contact ROBERT ABELS
Regulation Number876.5820
Classification Product Code
KPO  
Date Received06/05/1989
Decision Date 01/11/1990
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
-
-