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510(k) K083701

PANASIL INITIAL CONTACT AND PANASIL TRAY by Kettenbach GmbH & Co. KG — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2009
Date Received
December 15, 2008
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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