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FDA 510(k) Application Details - K003415
Device Classification Name
Blood Pressure Cuff
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510(K) Number
K003415
Device Name
Blood Pressure Cuff
Applicant
WANG & LI, INC.
2026 COYLE ST.
BROOKLYN, NY 11229 US
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Contact
ANN D MCGONIGLE
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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
11/02/2000
Decision Date
01/03/2001
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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