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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 K182191
Device Name Invia Abdominal Dressing Kit
Applicant
Medela AG
Laettichstrasse 4b
Baar Zug,  CH CH-6341
Applicant Contact Judith Bernardo
Correspondent
Hyman, Phelps & McNamara, PC
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact Adrienne Lenz
Regulation Number878.4780
Classification Product Code
OMP  
Subsequent Product Code
FTL  
Date Received08/13/2018
Decision Date 02/01/2019
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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