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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 K113236
Model NP32
Device Name FORYOU NPWT DEVICE
Applicant
FORYOU MEDICAL ELECTRONICS CO, LTD
3919 william penn highway,
suite 200
murrysville,  PA  15668
Contact scott wright
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/02/2011
Decision Date 02/12/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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