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FDA 510(k) Application Details - K031024
Device Classification Name
Meter, Peak Flow, Spirometry
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510(K) Number
K031024
Device Name
Meter, Peak Flow, Spirometry
Applicant
MICROLIFE CORP.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
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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
03/31/2003
Decision Date
11/14/2003
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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