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FDA 510(k) Application Details - K053149
Device Classification Name
Spirometer, Therapeutic (Incentive)
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510(K) Number
K053149
Device Name
Spirometer, Therapeutic (Incentive)
Applicant
LEVENTON, S.A.
C/NEWTON 18-24, POLIGONO
INDUSTRIAL SESROVIRES, SANT
ESTEVE SESROVIRES, BARCELONA 08635 ES
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ORIOL VERNIS
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Regulation Number
868.5690
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Classification Product Code
BWF
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Date Received
11/10/2005
Decision Date
12/13/2005
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
Y
Expedited Review
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