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 Tank, Holding, Dialysis
510(k) Number K970674
Device Name G.E.M. WATER SYSTEMS, INTERNATIONAL
Applicant
G.E.M. Water Systems
5940 Lakeshore Dr.
Cypress,  CA  90630
Applicant Contact JACK ENKOWITZ
Correspondent
G.E.M. Water Systems
5940 Lakeshore Dr.
Cypress,  CA  90630
Correspondent Contact JACK ENKOWITZ
Regulation Number876.5820
Classification Product Code
FIN  
Subsequent Product Code
KPO  
Date Received02/24/1997
Decision Date 11/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-