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FDA 510(k) Application Details - K992902
Device Classification Name
Catheters, Suction, Tracheobronchial
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510(K) Number
K992902
Device Name
Catheters, Suction, Tracheobronchial
Applicant
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM, MD 21090-1356 US
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Contact
SANJAY PARIKH
Other 510(k) Applications for this Contact
Regulation Number
868.6810
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Classification Product Code
BSY
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More FDA Info for this Product Code
Date Received
08/30/1999
Decision Date
10/25/1999
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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