FDA 510(k) Application Details - K965117

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K965117
Device Name Automated External Defibrillators (Non-Wearable)
Applicant NORTHROP GRUMMAN CORP.
8900 E. WASHINGTON BLVD.
PICO RIVERA, CA 90660 US
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Contact LOUIS S TOTH
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 12/20/1996
Decision Date 06/26/1998
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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