FDA 510(k) Application Details - K082056

Device Classification Name System, Gastrointestinal Motility (Electrical)

  More FDA Info for this Device
510(K) Number K082056
Device Name System, Gastrointestinal Motility (Electrical)
Applicant LIFE-TECH, INC.
4235 GREENBRIAR DR.
STAFFORD, TX 77477-3995 US
Other 510(k) Applications for this Company
Contact JEFF KASOFF
Other 510(k) Applications for this Contact
Regulation Number 876.1725

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

  More FDA Info for this Product Code
Date Received 07/21/2008
Decision Date 11/07/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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