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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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JOSH TRANTUM
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Regulation Number
870.5310
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Classification Product Code
MKJ
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More FDA Info for this Product Code
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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