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510(k) K071937

BONALIVE GRANULES AND BONALIVE PLATES by Vivoxid , Ltd. — Product Code KKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2007
Date Received
July 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class
Class II
Regulation Number
878.3500
Review Panel
SU
Submission Type

Other clearances by Vivoxid , Ltd.

  • K071199 — BONALIVE GRANULES (February 1, 2008)
  • K070055 — BONALIVE GRANULES AND BONALIVE PLATES (June 25, 2007)

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