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FDA 510(k) Application Details - K962872
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K962872
Device Name
Nebulizer (Direct Patient Interface)
Applicant
TYCO HEALTHCARE DEUTSCHALAND GMBH
RAFFINERIESTR. 18
NEUSTADT A D DONAU D-93333 DE
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Contact
WILLIAM D CURTIN
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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
07/23/1996
Decision Date
02/25/1997
Decision
SESD - SUBST EQUIV - WITH DRUG
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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