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FDA 510(k) Application Details - K952249
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K952249
Device Name
Nebulizer (Direct Patient Interface)
Applicant
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET, PA 15501-0635 US
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Contact
FRANK CLEMENTI
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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
05/15/1995
Decision Date
01/30/1996
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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