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510(k) K151271

BellaFuse by Hans Biomed Corp. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2016
Date Received
May 13, 2015
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 Hans Biomed Corp.

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  • K130235 — SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY (January 10, 2014)
  • K113728 — SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY (November 15, 2012)

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