FDA 510(k) Application Details - K991910

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K991910
Device Name Automated External Defibrillators (Non-Wearable)
Applicant PHYSIO-CONTROL CORP.
11811 WILLOWS RD. N.E.
P.O. BOX 97006
REDMOND, WA 98073-9706 US
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Contact MICHAEL D WILLINGHAM
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 06/07/1999
Decision Date 09/03/1999
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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