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510(k) K102758

TRULIGHT 5520 AND TRULIGHT 5320 by Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2010
Date Received
September 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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