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510(k) K113574

FLEXITIME MONOPHASE PRO SCAN by Heraeus Kulzer, LLC — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2012
Date Received
December 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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