FDA 510(k) Application Details - K090258

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

  More FDA Info for this Device
510(K) Number K090258
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant TALLEY MEDICAL
1070 E. WIELAND RD.
LANSING, MI 48906 US
Other 510(k) Applications for this Company
Contact JACK VAN DYKE
Other 510(k) Applications for this Contact
Regulation Number 878.4780

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

  More FDA Info for this Product Code
Date Received 02/02/2009
Decision Date 08/25/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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