FDA 510(k) Application Details - K032613

Device Classification Name Electrode, Pacemaker, Temporary

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510(K) Number K032613
Device Name Electrode, Pacemaker, Temporary
Applicant PETER M. ROTHENBERG, M.D.
657 CAMINO DE LOS MARES
SUITE 137
SAN CLEMENTE, CA 92673 US
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Contact PETER M ROTHENBERG
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Regulation Number 870.3680

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Classification Product Code LDF
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Date Received 08/25/2003
Decision Date 11/20/2003
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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