FDA 510(k) Application Details - K063602

Device Classification Name Compressor, Cardiac, External

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510(K) Number K063602
Device Name Compressor, Cardiac, External
Applicant ZOLL CIRCULATION
249 HUMBOLDT COURT
SUNNYVALE, CA 94089 US
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Contact MARK PERKINS
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Regulation Number 870.5200

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Classification Product Code DRM
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Date Received 12/04/2006
Decision Date 12/21/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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