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FDA 510(k) Application Details - K040723
Device Classification Name
Meter, Peak Flow, Spirometry
More FDA Info for this Device
510(K) Number
K040723
Device Name
Meter, Peak Flow, Spirometry
Applicant
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
868.1860
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Classification Product Code
BZH
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More FDA Info for this Product Code
Date Received
03/22/2004
Decision Date
06/10/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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