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510(k) K092218

FLEXICARE BREATHING FILTERS by Flexicare Medical, Ltd. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2009
Date Received
July 22, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
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)
  • K091591 — FLEXICARE MEDICAL ENDOTRACHEAL TUBES (June 17, 2009)
  • K951652 — VENTIMASK MK IV (April 27, 1995)

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