FDA 510(k) Application Details - K024009

Device Classification Name Unit, Cryosurgical, Accessories

  More FDA Info for this Device
510(K) Number K024009
Device Name Unit, Cryosurgical, Accessories
Applicant H&O EQUIPMENTS NV/SA
4655 KIRKWOOD CT.
BOULDER, CO 80301 US
Other 510(k) Applications for this Company
Contact LEWIS WARD
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 12/04/2002
Decision Date 03/20/2003
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