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510(k) K151154

FIBERGRAFT BG Morsels by Prosidyan, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2015
Date Received
April 30, 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

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  • K143533 — FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE (March 25, 2015)
  • K141956 — FIBERGRAFT BG MORSELS (August 13, 2014)

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