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510(k) K091591

FLEXICARE MEDICAL ENDOTRACHEAL TUBES by Flexicare Medical, Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2009
Date Received
June 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Flexicare Medical, Ltd.

  • K150900 — Flexicare Heated Wire Breathing Systems (May 15, 2015)
  • K140473 — DUALGUARD (April 10, 2014)
  • K140113 — O2 NASAL CANNULA WITH CO2 MONITORING (March 6, 2014)
  • K132619 — CLASSIC INTERMITTENT CATHETER (October 11, 2013)
  • K092218 — FLEXICARE BREATHING FILTERS (October 6, 2009)
  • K951652 — VENTIMASK MK IV (April 27, 1995)

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