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FDA 510(k) Application Details - K021389
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K021389
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
Other 510(k) Applications for this Contact
Regulation Number
870.1875
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Classification Product Code
DQD
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More FDA Info for this Product Code
Date Received
05/02/2002
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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