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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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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