FDA 510(k) Application Details - K934067

Device Classification Name Dc-Defibrillator, High Energy, (Including Paddles)

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510(K) Number K934067
Device Name Dc-Defibrillator, High Energy, (Including Paddles)
Applicant NATIONAL CUSTOM ENT., INC.
400 GATEWAY BLVD.
BURNSVILLE, MN US
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Contact MIKE BENYO
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Regulation Number 870.5300

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Classification Product Code DRK
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Date Received 08/20/1993
Decision Date 10/07/1993
Decision SE - Substantially Equivalent
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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