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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 Device For Reduction Of Wound Complications
510(k) Number K223263
Device Name Prevena Plus 125 Therapy Unit
Applicant
3M
6203 Farinon Dr.
San Antionio,  TX  78247
Applicant Contact Teri Feeley
Correspondent
3M
6203 Farinon Dr.
San Antionio,  TX  78247
Correspondent Contact Teri Feeley
Regulation Number878.4783
Classification Product Code
QFC  
Date Received10/24/2022
Decision Date 02/13/2023
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
Recalls CDRH Recalls
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