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510(k) K131254

KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE by Kimberly-Clark Corp. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2013
Date Received
May 2, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

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  • K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING (December 19, 2012)
  • K112805 — KIMGUARD ONE-STEP STERILIZATION WRAP (June 22, 2012)
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  • K113423 — KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE (March 9, 2012)
  • K112300 — KIMGUARD SMART-FOLD* STERILIZATION WRAP (January 19, 2012)
  • K112562 — BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER (December 15, 2011)

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