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 System, Water Purification, General Medical Use
510(k) Number K191563
Device Name FILTRAY 2G Disposable Water Filters
Applicant
Aqua-Tools
26, Rue Charles Edouard Jeanneret
Poissy,  FR 78300
Applicant Contact Virginie S. Grondin
Correspondent
Aqua-Tools
26, Rue Charles Edouard Jeanneret
Poissy,  FR 78300
Correspondent Contact Virginie S. Grondin
Regulation Number876.5665
Classification Product Code
NHV  
Date Received06/13/2019
Decision Date 10/25/2019
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
-
-