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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name negative pressure wound therapy powered suction pump
510(k) Number K121817
Device Name VCARE A
Original Applicant
IVT MEDICAL LTD
pob 6718
efrat,  IS 91435
Original Contact eli orbach
Regulation Number878.4780
Classification Product Code
OMP  
Date Received06/20/2012
Decision Date 09/17/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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