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510(k) K140680

LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM by Alpine Biomed Aps — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2014
Date Received
March 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

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