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510(k) K120392

CHROMOPHARE F 628 AND F 528 by Berchtold GmbH & Co. KG — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2012
Date Received
February 8, 2012
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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