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510(k) K101617

FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL by Heraeus Kulzer, LLC — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2010
Date Received
June 9, 2010
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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