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FDA 510(k) Application Details - K030417
Device Classification Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
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510(K) Number
K030417
Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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Contact
PETER OHANIAN
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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
02/10/2003
Decision Date
05/09/2003
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
N
Expedited Review
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