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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 K170088
Device Name Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
Applicant
MEDELA, AG
Lattichstrasse 4b
Baar,  CH 6341
Applicant Contact Markus Butler
Correspondent
PROSYSTEM AG
Beim Strohhause 17
HAMBURG,  DE 20097
Correspondent Contact Julian Thorns
Regulation Number878.4780
Classification Product Code
OMP  
Date Received01/10/2017
Decision Date 04/06/2017
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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