FDA 510(k) Application Details - K122259

Device Classification Name Blood Pressure Cuff

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510(K) Number K122259
Device Name Blood Pressure Cuff
Applicant HANGZHOU RELI-ON CO., LTD
77325 JOYCE WAY
ECHO, OR 97826 US
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Contact CHARILE MACK
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 07/27/2012
Decision Date 09/24/2012
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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