FDA 510(k) Application Details - K073079

Device Classification Name Compressor, Cardiac, External

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510(K) Number K073079
Device Name Compressor, Cardiac, External
Applicant MICHIGAN INSTRUMENTS, INC.
555 THIRTEENTH ST., NW
WASHINGTON, DC 20004 US
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Contact HOWARD M HOSTEIN
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Regulation Number 870.5200

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Classification Product Code DRM
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Date Received 10/31/2007
Decision Date 02/14/2008
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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