FDA 510(k) Application Details - K952713

Device Classification Name Meter, Peak Flow, Spirometry

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510(K) Number K952713
Device Name Meter, Peak Flow, Spirometry
Applicant CLEMENT CLARKE, INC.
AIRMED HOUSE, EDINBURGH WAY
HARLOW, ESSEX CM20 2ED
ENGLAND GB
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Contact MICHAEL J WILKINSON
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Regulation Number 868.1860

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Classification Product Code BZH
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Date Received 06/14/1995
Decision Date 03/29/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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