FDA 510(k) Application Details - K053364

Device Classification Name Lamp, Surgical

  More FDA Info for this Device
510(K) Number K053364
Device Name Lamp, Surgical
Applicant WALDMANN LIGHTING
PO BOX 7007
DEERFIELD, IL 6015 US
Other 510(k) Applications for this Company
Contact DANIEL KAMM
Other 510(k) Applications for this Contact
Regulation Number 878.4580

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

  More FDA Info for this Product Code
Date Received 12/02/2005
Decision Date 02/23/2006
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