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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 K150459
Device Name FloSure Ventilation Patch
Applicant
Simex Medizintechnik GmbH
Post Box 1207
Deisslingen,  DE D-78649
Applicant Contact Hamid Khosrowshahi
Correspondent
Flosure Technologies, LLC
P.O. Box 123
Tarrytown,  NY  10591
Correspondent Contact Hamid Khosrowshahi
Regulation Number878.4780
Classification Product Code
OMP  
Date Received02/23/2015
Decision Date 01/05/2016
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
Predetermined Change
Control Plan Authorized		 No
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