FDA 510(k) Application Details - K030556

Device Classification Name Electrode, Pacemaker, Temporary

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510(K) Number K030556
Device Name Electrode, Pacemaker, Temporary
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact GEORG KELLER
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Regulation Number 870.3680

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Classification Product Code LDF
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Date Received 02/21/2003
Decision Date 04/22/2003
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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