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510(k) K171568

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty by Hans Biomed Corporation — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2018
Date Received
May 30, 2017
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

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  • K130191 — MINT (June 12, 2013)

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