FDA 510(k) Application Details - K022298

Device Classification Name Stethoscope, Electronic

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510(K) Number K022298
Device Name Stethoscope, Electronic
Applicant ANDROMED, INC.
4610 CHEMIN DU BOIS-FRANC
SAINT LAURENT, QUEBEC H4S 1A7 CA
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Contact GENEVIEVE HAMEL
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 07/16/2002
Decision Date 10/01/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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