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FDA 510(k) Application Details - K140634
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K140634
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
Devon Medical, Inc.
1100 First Avenue, Suite 202
King of Prussia, PA 19406 US
Other 510(k) Applications for this Company
Contact
Steve XU
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
03/12/2014
Decision Date
09/19/2014
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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