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FDA 510(k) Application Details - K990185
Device Classification Name
Nebulizer (Direct Patient Interface)
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510(K) Number
K990185
Device Name
Nebulizer (Direct Patient Interface)
Applicant
MEDTRAK TECHNOLOGIES, INC.
6950 WEST JEFFERSON AVE., #210
LAKEWOOD, CO 80235 US
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Contact
LINDA L 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
01/20/1999
Decision Date
04/01/1999
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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