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FDA 510(k) Application Details - K953411
Device Classification Name
Meter, Peak Flow, Spirometry
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510(K) Number
K953411
Device Name
Meter, Peak Flow, Spirometry
Applicant
ROXON - UNIVERSAL MEDICAL LTD.
141, EAST - COLUMBIA ST.
NEW WESTMINISTER, B.C. V3L 3V9 CA
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MO SHARIFF
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Regulation Number
868.1860
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Classification Product Code
BZH
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Date Received
07/20/1995
Decision Date
06/13/1996
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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