FDA 510(k) Application Details - K051021

Device Classification Name Blood Pressure Cuff

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510(K) Number K051021
Device Name Blood Pressure Cuff
Applicant SHANGHAI LORD INTERNATIONAL TRADE CO., LTD.
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 04/22/2005
Decision Date 06/20/2005
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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