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510(k) K080549

DURAFINISH ALL-CURE, MODEL S296 by Parkell, Inc. — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2008
Date Received
February 27, 2008
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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