FDA 510(k) Application Details - K071140

Device Classification Name Tourniquet, Pneumatic

  More FDA Info for this Device
510(K) Number K071140
Device Name Tourniquet, Pneumatic
Applicant TOPSPINS, INC.
403 RIVERVIEW DR
ANN ARBOR, MI 48107-7205 US
Other 510(k) Applications for this Company
Contact ERIN BUETHE
Other 510(k) Applications for this Contact
Regulation Number 878.5910

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

  More FDA Info for this Product Code
Date Received 04/24/2007
Decision Date 06/07/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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