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510(k) K182084

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) by Sweden & Martina S.P.A. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2020
Date Received
August 2, 2018
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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  • K162028 — PREMIUM - SHELTA Prosthetic Components (March 24, 2017)
  • K162004 — PREMIUM Implant Systems SHELTA Implant Systems (December 5, 2016)
  • K142242 — PREMIUM, SHELTA Implant Systems (February 2, 2015)

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