FDA 510(k) Application Details - K130249

Device Classification Name Equipment, Traction, Powered

  More FDA Info for this Device
510(K) Number K130249
Device Name Equipment, Traction, Powered
Applicant INTEGRITY LIFE SCIENCES
2189 WEST BUSCH BLVD
TAMPA, FL 33612 US
Other 510(k) Applications for this Company
Contact JAMES J GIBSON
Other 510(k) Applications for this Contact
Regulation Number 890.5900

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

  More FDA Info for this Product Code
Date Received 02/01/2013
Decision Date 02/06/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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