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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 K241061
Device Name VERSA Negative Pressure Wound Therapy System (VCMPP-100)
Applicant
Cork Medical
8000 Castleway Dr.
Indianapolis,  IN  46250
Applicant Contact Antonio Williams
Correspondent
Cork Medical
8000 Castleway Dr.
Indianapolis,  IN  46250
Correspondent Contact Antonio Williams
Regulation Number878.4780
Classification Product Code
OMP  
Date Received04/18/2024
Decision Date 08/21/2024
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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