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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 K172145
Device Name Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
Applicant
Medela AG
Lattichstrasse 4b
Baar,  CH 6341
Applicant Contact Georges Hakim
Correspondent
Hyman, Phelps & McNamara, PC
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005 - 592
Correspondent Contact Adrienne Lenz
Regulation Number878.4780
Classification Product Code
OMP  
Date Received07/17/2017
Decision Date 05/09/2018
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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