FDA 510(k) Application Details - K140874

Device Classification Name Blood Pressure Cuff

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510(K) Number K140874
Device Name Blood Pressure Cuff
Applicant SHANGHAI GOAHUI RUBBER AND PLASTIC COMPANY
144 RESEARCG DRIVE
HAMPTON, VA 23666 US
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Contact RHONDA ALEXANDER, MS, MPA
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 04/04/2014
Decision Date 09/02/2014
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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