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510(k) K041363

AOC BONE WAX by Ceremed , Inc. — Product Code MTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2004
Date Received
May 21, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wax, Bone
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

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  • K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (November 27, 2012)
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  • K103047 — CERETENE SOLUBLE IMPLANT MATERIAL (January 5, 2011)
  • K102071 — OSTENE CT, AOC CT, OSTEOTENE, CERETENE (October 8, 2010)
  • K091636 — OSTENE CT, AOC CT, OSTEOTENE, CERETENE (June 22, 2009)
  • K082491 — OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTE (September 24, 2008)

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