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510(k) K102770

FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW by Heraeus Kulzer, LLC — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2010
Date Received
September 24, 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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