FDA 510(k) Application Details - K073089

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K073089
Device Name Automated External Defibrillators (Non-Wearable)
Applicant PHYSIO-CONTROL, INC.
11811 WILLOWS RD., N.E.
PO BOX 97006
REDMOND, WA 98052 US
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Contact MICHELLE ACKERMANN
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 11/01/2007
Decision Date 07/29/2008
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 N
Expedited Review



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