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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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More FDA Info for this Product Code
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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