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510(k) K142090

REBOSSIS by Orthorebirth Co., Ltd. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2014
Date Received
August 1, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

Other clearances by Orthorebirth Co., Ltd.

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