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510(k) K153095

ROP Resorbable Hemostasis Material by Resorbable Orthopedic Products, LLC — Product Code MTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2016
Date Received
October 26, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wax, Bone
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

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