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FDA 510(k) Application Details - K964130
Device Classification Name
Meter, Peak Flow, Spirometry
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510(K) Number
K964130
Device Name
Meter, Peak Flow, Spirometry
Applicant
MONAGHAN MEDICAL CORP.
5 LATOUR AVE., SUITE 1600
PLATTSBURGH, NY 12901 US
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Contact
JAMES A COCHIE
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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
10/15/1996
Decision Date
01/10/1997
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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