FDA 510(k) Application Details - K022732

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K022732
Device Name Automated External Defibrillators (Non-Wearable)
Applicant MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD., N.E.
REDMOND, WA 98073 US
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Contact SHERRI L POCOCK
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 08/16/2002
Decision Date 12/13/2002
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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