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510(k) K011132

AIRLIFE HEPA FILTER by Allegiance Healthcare Corp. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2001
Date Received
April 13, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Allegiance Healthcare Corp.

  • K023673 — AIRLIFE DEMAND NASAL CANNULA (May 2, 2003)
  • K023419 — TRILAMINATE DRAPES/TIBURON (February 11, 2003)
  • K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES (January 15, 2003)
  • K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN (January 9, 2003)
  • K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (December 18, 2002)
  • K023425 — DRAPES WITH ABSORBENT REINFORCEMENT (November 6, 2002)
  • K022765 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 11, 2002)
  • K023170 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 9, 2002)
  • K023167 — BREATHABLE SURGICAL GOWN (October 2, 2002)
  • K012931 — GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM (August 20, 2002)

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