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FDA 510(k) Application Details - K121817
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K121817
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
IVT MEDICAL LTD
POB 6718
EFRAT 91435 IL
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Contact
ELI ORBACH
Other 510(k) Applications for this Contact
Regulation Number
878.4780
More FDA Info for this Regulation Number
Classification Product Code
OMP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/20/2012
Decision Date
09/17/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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