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510(k) K082338

POLYBONE GRANULE & BLOCK by Kyung Won Medical Co., Ltd. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2008
Date Received
August 14, 2008
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 Kyung Won Medical Co., Ltd.

  • K100373 — TYCHE PEDICLE SCREW SYSTEM (June 30, 2010)
  • K092194 — POLYBONE DENTAL (June 16, 2010)
  • K070012 — POLYBONE (December 27, 2007)

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