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FDA 510(k) Application Details - K970344
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K970344
Device Name
Nebulizer (Direct Patient Interface)
Applicant
MEDTRAK TECHNOLOGIES, INC.
12364 W. ALAMEDA PKWY.
SUITE 115
LAKEWOOD, CO 80228 US
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Contact
LINDA NELSON
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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
01/29/1997
Decision Date
08/06/1997
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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