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510(k) K120914

FLEXITIME FAST & SCAN LIGHT FLOW by Heraeus Kulzer, LLC — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2012
Date Received
March 27, 2012
Clearance Type
Special
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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  • K093575 — GLUMA DESENSITIZER POWER GEL (March 5, 2010)
  • K091635 — VENUS DIAMOND FLOW (September 3, 2009)

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