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510(k) K132242

INNO SLA SUBMERGED IMPLANT SYSTEM by Cowellmedi Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2013
Date Received
July 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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