FDA 510(k) Application Details - K963095

Device Classification Name Meter, Peak Flow, Spirometry

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510(K) Number K963095
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
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Regulation Number 868.1860

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Classification Product Code BZH
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Date Received 08/08/1996
Decision Date 11/04/1996
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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