FDA 510(k) Application Details - K992793

Device Classification Name Tank, Holding, Dialysis

  More FDA Info for this Device
510(K) Number K992793
Device Name Tank, Holding, Dialysis
Applicant BETTER WATER, INC.
698 SWAN DR.
SMYRNA, TN 37167 US
Other 510(k) Applications for this Company
Contact MIKE S STERLING
Other 510(k) Applications for this Contact
Regulation Number 876.5820

  More FDA Info for this Regulation Number
Classification Product Code FIN
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/19/1999
Decision Date 11/16/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact