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FDA 510(k) Application Details - K080421
Device Classification Name
Automated External Defibrillators (Non-Wearable)
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510(K) Number
K080421
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
HEART SYNC LLC
5643 PLYMOUTH ROAD
ANN ARBOR, MI 48105 US
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Contact
STEPHEN SHULMAN
Other 510(k) Applications for this Contact
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
02/15/2008
Decision Date
02/29/2008
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
Y
Expedited Review
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