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510(k) K102071

OSTENE CT, AOC CT, OSTEOTENE, CERETENE by Ceremed , Inc. — Product Code MTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2010
Date Received
July 23, 2010
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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  • K103047 — CERETENE SOLUBLE IMPLANT MATERIAL (January 5, 2011)
  • 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)
  • K082245 — AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (September 18, 2008)

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