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510(k) K092551

SMITH & NEPHEW INSTRUMENT TRAYS by Smith & Nephew Inc., Endoscopy Div. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2010
Date Received
August 20, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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  • K093943 — BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM (March 5, 2010)
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  • K073551 — SMITH & NEPHEW INSTRUMENT TRAYS (May 21, 2008)
  • K080358 — PLLA, HA SCREW (April 23, 2008)
  • K063726 — PLC SUTURE ANCHOR (March 6, 2007)

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