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FDA 510(k) Application Details - K100380
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K100380
Device Name
Nebulizer (Direct Patient Interface)
Applicant
PARI RESPIRATORY EQUIPMENT, INC.
2943 OAKLAKE BLVD.
MIDLOTHIAN, VA 23112 US
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Contact
JAMES L MCINTIRE
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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
02/16/2010
Decision Date
02/22/2010
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
N
Expedited Review
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