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510(k) K151166

Instru-Safe Instrument Protection System by Summit Medical, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2015
Date Received
May 1, 2015
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

Other clearances by Summit Medical, Inc.

  • K180528 — InstruSafe(R) Sterilization Container (November 16, 2018)
  • K173110 — GRAFTSITE (May 18, 2018)
  • K170388 — ANCHORMAN Tibial Ligament Fixation Device (July 25, 2017)
  • K162046 — MINNE TIES MMF Suture System (April 11, 2017)
  • K150540 — Instru-Safe Instrument Protection System (June 22, 2015)
  • K142768 — Instru-Safe Instrument Protection System (May 29, 2015)
  • K142630 — Instru-Safe Instrument Protection System (December 23, 2014)
  • K141513 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (December 15, 2014)
  • K140289 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (June 27, 2014)
  • K133015 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (March 13, 2014)

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