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FDA 510(k) Application Details - K040718
Device Classification Name
Nebulizer (Direct Patient Interface)
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510(K) Number
K040718
Device Name
Nebulizer (Direct Patient Interface)
Applicant
DHD HEALTHCARE CORP.
ONE MADISON ST.
WAMPSVILLE, NY 13163 US
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Contact
DAVID GEARY
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Regulation Number
868.5630
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Classification Product Code
CAF
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More FDA Info for this Product Code
Date Received
03/19/2004
Decision Date
04/02/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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