FDA 510(k) Application Details - K093310

Device Classification Name Device,Anastomotic,Microvascular

  More FDA Info for this Device
510(K) Number K093310
Device Name Device,Anastomotic,Microvascular
Applicant SYNOVIS MICRO COMPANIES ALLIANCE, INC.
2575 UNIVERSITY AVE.
SAINT PAUL, MN 55114-1024 US
Other 510(k) Applications for this Company
Contact MELISSA J FORTH
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 10/22/2009
Decision Date 02/01/2010
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