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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 K203693
Device Name Nisus Touch Negative Pressure Wound Therapy Pump
Applicant
Cork Medical Products, LLC
8000 Castleway Dr.
Indianapolis,  IN  46250
Applicant Contact Patrick McGinley
Correspondent
Cork Medical Products, LLC
8000 Castleway Dr.
Indianapolis,  IN  46250
Correspondent Contact Patrick McGinley
Regulation Number878.4780
Classification Product Code
OMP  
Date Received12/18/2020
Decision Date 08/13/2021
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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