FDA 510(k) Application Details - K081951

Device Classification Name Blood Pressure Cuff

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510(K) Number K081951
Device Name Blood Pressure Cuff
Applicant WENZHOU KINDCARE IMPORT & EXPORT CO., LTD
340 SHADY GROVE ROAD
FLINTVILLE, TN 37335 US
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Contact CHARLIE MACK
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 07/09/2008
Decision Date 08/15/2008
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 Y
Expedited Review



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