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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 K113291
Device Name SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300
Original Applicant
SIMEX MEDIZINTECHNIK GMBH
p.o. box 1207
deisslingen,  DE d-78649
Original Contact hamid khosrowshahi
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/08/2011
Decision Date 08/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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