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510(k) K182107

CarriGen PF by Etex Corporation — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2018
Date Received
August 3, 2018
Clearance Type
Special
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

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