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510(k) K052935

HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) by Heidelberg Engineering — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2006
Date Received
October 19, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

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