FDA 510(k) Application Details - K051904

Device Classification Name Blood Pressure Cuff

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510(K) Number K051904
Device Name Blood Pressure Cuff
Applicant SUNTECH MEDICAL, INC.
507 AIRPORT BOULEVARD
SUITE 117
MORRISVILLE, NC 27560 US
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Contact DAVID GALLICK
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 07/13/2005
Decision Date 09/09/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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