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FDA 510(k) Application Details - K030396
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K030396
Device Name
Nebulizer (Direct Patient Interface)
Applicant
B & B MEDICAL TECHNOLOGIES, INC.
6731 32ND ST., SUITE A&B
NORTH HIGHLANDS, CA 95660 US
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Contact
STEPHEN W BRIGGS
Other 510(k) Applications for this Contact
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
02/06/2003
Decision Date
05/07/2004
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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