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FDA 510(k) Application Details - K990809
Device Classification Name
Stethoscope, Electronic
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510(K) Number
K990809
Device Name
Stethoscope, Electronic
Applicant
CADITEC AG
ONE MEDICAL PLACE
MUNDELEIN, IL 60060 US
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BETTY LOCK
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Regulation Number
870.1875
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Classification Product Code
DQD
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Date Received
03/11/1999
Decision Date
06/09/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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