FDA 510(k) Application Details - K024156

Device Classification Name Pacemaker Lead Adaptor

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510(K) Number K024156
Device Name Pacemaker Lead Adaptor
Applicant Oscor Inc.
3816 DE SOTO BLVD.
PALM HARBOR, FL 34683 US
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Contact MILA DOSKOCIL
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Regulation Number 870.3620

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Classification Product Code DTD
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Date Received 12/17/2002
Decision Date 01/14/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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