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510(k) K180528

InstruSafe(R) Sterilization Container by Summit Medical, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2018
Date Received
February 28, 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

Other clearances by Summit Medical, Inc.

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  • K162046 — MINNE TIES MMF Suture System (April 11, 2017)
  • K151166 — Instru-Safe Instrument Protection System (August 18, 2015)
  • 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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