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510(k) K130991

NEXXZR(TM)T AND NEXXZR(TM)S by Sagemax Bioceramics, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2014
Date Received
April 10, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

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