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510(k) K133015

INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM by Summit Medical, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2014
Date Received
September 25, 2013
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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  • K170388 — ANCHORMAN Tibial Ligament Fixation Device (July 25, 2017)
  • 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)

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