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510(k) K063228

SURFACE COAT by Kuraray America, Inc. — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2006
Date Received
October 25, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
Review Panel
DE
Submission Type

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