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510(k) K151594

Ellipse Supplemental Instrument Trays by Ellipse Technologies, Incorporated — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2016
Date Received
June 12, 2015
Clearance Type
Abbreviated
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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  • K150656 — PRECICE Intramedullary Limb Lengthening System (April 23, 2015)
  • K142599 — PRECISE Trauma Nail System (January 16, 2015)

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