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 Set, Administration, For Peritoneal Dialysis, Disposable
510(k) Number K151620
Device Name Firefly Peritoneal Dialysis Connector Disinfection System
Applicant
Puracath Medical, Inc.
660 4th St. #104
San Francisco,  CA  94107
Applicant Contact JOHN ASHLEY
Correspondent
Puracath Medical, Inc.
660 4th St. #104
San Francisco,  CA  94107
Correspondent Contact JOHN ASHLEY
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received06/16/2015
Decision Date 01/20/2016
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
-
-