FDA 510(k) Application Details - K061317

Device Classification Name Light, Surgical, Ceiling Mounted

  More FDA Info for this Device
510(K) Number K061317
Device Name Light, Surgical, Ceiling Mounted
Applicant TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG
BENZSTRASSE 26
MUNCHEN 82178 DE
Other 510(k) Applications for this Company
Contact WILLIBALD HIEMER
Other 510(k) Applications for this Contact
Regulation Number 878.4580

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

  More FDA Info for this Product Code
Date Received 05/11/2006
Decision Date 06/22/2006
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 Y
Expedited Review

FDA Source Information for K061317


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