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FDA 510(k) Application Details - K042302
Device Classification Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
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510(K) Number
K042302
Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant
ZOLL MEDICAL CORP.
269 MILL ROAD
CHELMSFORD, MA 01824-4105 US
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Contact
SEAN REYNOLDS
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Regulation Number
870.5300
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Classification Product Code
LDD
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More FDA Info for this Product Code
Date Received
08/25/2004
Decision Date
10/26/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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