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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 K143004
Device Name VENTURI MiNO TG600/14
Applicant
Talley Group, Ltd.
Premier Way,
Abbey Park Industrial Estate
Romsey,  GB SO51 9DQ
Applicant Contact ROBERT WILLIAM MACDONALD
Correspondent
Talley Group, Ltd.
Premier Way, Abbey Park Industrial Estate
Romsey,  GB SO51 9DQ
Correspondent Contact ROBERT WILLIAM MACDONALD
Regulation Number878.4780
Classification Product Code
OMP  
Date Received10/20/2014
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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