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 K171750
Device Name Citric Complete Dry Citric Acid (45X)
Applicant
Dimesol USA, LLC
509 Fishing Creek Rd.
Lewisberry,  PA  17339
Applicant Contact Marlene Van Dyke
Correspondent
Mcnees Wallace & Nurick, LLC
21 E. State St., Suite 1700
Columbus,  OH  43215
Correspondent Contact David M. Marcus
Regulation Number876.5820
Classification Product Code
KPO  
Date Received06/13/2017
Decision Date 03/06/2018
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-