FDA 510(k) Application Details - K102823

Device Classification Name Blood Pressure Cuff

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510(K) Number K102823
Device Name Blood Pressure Cuff
Applicant WUXI MEDICAL INSTRUMENT FACTORY
P.O. BOX 237-023
SHANGHAI 200237 CN
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Contact Diana Hong
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 09/29/2010
Decision Date 01/07/2011
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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