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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
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