FDA 510(k) Application Details - K043444

Device Classification Name Blood Pressure Cuff

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510(K) Number K043444
Device Name Blood Pressure Cuff
Applicant GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.
1800 CENTURY PARK EAST
SUITE 600
LOS ANGELES, CA 90067 US
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Contact GEORGE SU
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 12/14/2004
Decision Date 02/22/2005
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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