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510(k) K162568

INTRABEAM 600 by Carl Zeiss Meditec, AG — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2016
Date Received
September 14, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Therapeutic, X-Ray
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type

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