FDA 510(k) Application Details - K070674

Device Classification Name Holding Chambers, Direct Patient Interface

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510(K) Number K070674
Device Name Holding Chambers, Direct Patient Interface
Applicant TRUDELL MEDICAL INTL.
725 THIRD ST.
LONDON, ONTARIO N5V 5G4 CA
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Contact JOHN STRAATMAN
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Regulation Number 868.5630

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Classification Product Code NVP
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Date Received 03/12/2007
Decision Date 04/11/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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