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FDA 510(k) Application Details - K113291
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K113291
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
SIMEX MEDIZINTECHNIK GMBH
P.O. BOX 1207
DEISSLINGEN D-78649 DE
Other 510(k) Applications for this Company
Contact
HAMID KHOSROWSHAHI
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
11/08/2011
Decision Date
08/30/2012
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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