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510(k) K113279

IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT by Kettenbach GmbH & Co. KG — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2011
Date Received
November 7, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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