FDA 510(k) Application Details - K982334

Device Classification Name Meter, Peak Flow, Spirometry

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510(K) Number K982334
Device Name Meter, Peak Flow, Spirometry
Applicant CLEMENT CLARKE INTL., LTD.
EDINBURGH WAY
HARLOW CM20 2TT GB
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Contact M J WILKINSON
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Regulation Number 868.1860

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Classification Product Code BZH
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Date Received 07/02/1998
Decision Date 01/14/1999
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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