FDA 510(k) Application Details - K152801

Device Classification Name Blood Pressure Cuff

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510(K) Number K152801
Device Name Blood Pressure Cuff
Applicant STATCORP MEDICAL
14476 Duval Place West
Suite 303
JACKSONVILLE, FL 32218 US
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Contact WAYNE EMMERT
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 09/28/2015
Decision Date 10/27/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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