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FDA 510(k) Application Details - K001306
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K001306
Device Name
Stethoscope, Electronic
Applicant
ANDROMED, INC.
2310 BOUL ALFRED-NOBEL
ST.LAURENT, QUEBEC H4S 2A4 CA
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Contact
JEAN DUMAS
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
04/25/2000
Decision Date
07/20/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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