FDA 510(k) Application Details - K082074

Device Classification Name Unit, Cryosurgical, Accessories

  More FDA Info for this Device
510(K) Number K082074
Device Name Unit, Cryosurgical, Accessories
Applicant ATRICURE, INC.
6033 SCHUMACHER PARK DR.
WEST CHESTER, OH 45069 US
Other 510(k) Applications for this Company
Contact JAMES LUCKY
Other 510(k) Applications for this Contact
Regulation Number 878.4350

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

  More FDA Info for this Product Code
Date Received 07/23/2008
Decision Date 03/02/2009
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 Y
Expedited Review



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