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FDA 510(k) Application Details - K980960
Device Classification Name
Meter, Peak Flow, Spirometry
More FDA Info for this Device
510(K) Number
K980960
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
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
03/16/1998
Decision Date
06/10/1998
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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