FDA 510(k) Application Details - K022345

Device Classification Name Compressor, Cardiac, External

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510(K) Number K022345
Device Name Compressor, Cardiac, External
Applicant REVIVANT CORP.
775 PALOMAR AVE.
SUNNYVALE, CA 94085 US
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Contact SUSANNE T SMITH
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Regulation Number 870.5200

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Classification Product Code DRM
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Date Received 07/19/2002
Decision Date 08/15/2002
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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