FDA 510(k) Application Details - K960329

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K960329
Device Name Automated External Defibrillators (Non-Wearable)
Applicant CONTOUR MEDICAL TECHNOLOGY, INC.
144 BAIN ST.
LAVERGNE, TN 37086 US
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Contact JOSH TRANTUM
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 01/24/1996
Decision Date 07/02/1996
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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