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FDA 510(k) Application Details - K112853
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K112853
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
SUZRIC ENTERPRISE CO., LTD.
NO. 77, KEJI 2ST ROAD
GUISHAN TOWNSHIP
TAOYUAN COUNTY 333 TW
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Contact
MICHAEL LEE
Other 510(k) Applications for this Contact
Regulation Number
878.4780
More FDA Info for this Regulation Number
Classification Product Code
OMP
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More FDA Info for this Product Code
Date Received
09/29/2011
Decision Date
11/09/2012
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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