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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 K214112
Device Name Invia Ease Negative Pressure Wound Therapy (NPWT) System
Applicant
Medela AG
Lattichstrasse 4b
Baar,  CH 6340
Applicant Contact Mike McAndrew
Correspondent
Medela AG
Lattichstrasse 4b
Baar,  CH 6340
Correspondent Contact Mike McAndrew
Regulation Number878.4780
Classification Product Code
OMP  
Date Received12/30/2021
Decision Date 07/26/2022
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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