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FDA 510(k) Application Details - K971436
Device Classification Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
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510(K) Number
K971436
Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant
NIHON KOHDEN AMERICA, INC.
2601 CAMPUS DR.
IRVINE, CA 92612-1601 US
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GARY REASONER
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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
04/18/1997
Decision Date
10/21/1997
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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