FDA 510(k) Application Details - K110853

Device Classification Name Tube, Feeding

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510(K) Number K110853
Device Name Tube, Feeding
Applicant VR MEDICAL
90 GAO XIN ROAD
ZHOUZHUANG 215325 CN
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Contact LEE PAN
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Regulation Number 876.5980

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Classification Product Code FPD
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Date Received 03/28/2011
Decision Date 05/13/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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