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FDA 510(k) Application Details - K963621
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K963621
Device Name
Stethoscope, Electronic
Applicant
THERATECHNOLOGIES, INC.
7701, 17TH AVENUE
MONTREAL, QUEBEC H2A 2S5 CA
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Contact
MICHEL GUERETTE
Other 510(k) Applications for this Contact
Regulation Number
870.1875
More FDA Info for this Regulation Number
Classification Product Code
DQD
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More FDA Info for this Product Code
Date Received
09/06/1996
Decision Date
12/04/1996
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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