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510(k) K032972

AEROCHAMBER MAX VALVED HOLDING CHAMBER by Trudell Medical Intl. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2004
Date Received
September 24, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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  • K053605 — AEROECLIPSE II BREATH ACTUATED NEBULIZER (February 27, 2006)
  • K052332 — AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER (September 21, 2005)

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