FDA 510(k) Application Details - K141998

Device Classification Name Blood Pressure Cuff

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510(K) Number K141998
Device Name Blood Pressure Cuff
Applicant PINGHU SAMA MEDICAL PACKING CO., LTD.
853 DORCHESTER LN, UNIT-B
NEW MILFORD, NJ 07646 US
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Contact CHARLES SHEN
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 07/23/2014
Decision Date 09/19/2014
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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