FDA 510(k) Application Details - K021340

Device Classification Name Device, Counter-Pulsating, External

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510(K) Number K021340
Device Name Device, Counter-Pulsating, External
Applicant EXTERNAL COUNTERPULSATION LAB
85 WU JIN ROAD
SHANGHAI 200080 CN
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Contact DAWEI CAI
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Regulation Number 870.5225

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Classification Product Code DRN
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Date Received 04/26/2002
Decision Date 01/30/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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