FDA 510(k) Application Details - K963621

Device Classification Name Stethoscope, Electronic

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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
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Regulation Number 870.1875

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Classification Product Code DQD
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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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