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FDA 510(k) Application Details - K963089
Device Classification Name
Meter, Peak Flow, Spirometry
More FDA Info for this Device
510(K) Number
K963089
Device Name
Meter, Peak Flow, Spirometry
Applicant
MONAGHAN MEDICAL CORP.
5 LATOUR AVE., SUITE 1600
P.O. BOX 2805
PLATTSBURGH, NY 12901 US
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Contact
JAMES A COCHIE
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
08/08/1996
Decision Date
11/06/1996
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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