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FDA 510(k) Application Details - K982722
Device Classification Name
Nebulizer (Direct Patient Interface)
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510(K) Number
K982722
Device Name
Nebulizer (Direct Patient Interface)
Applicant
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM, MD 21090-1356 US
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Contact
SANJAY PARIKH
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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
08/05/1998
Decision Date
04/12/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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