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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 K113678
Device Name INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Applicant
Medela AG
W324 S3649 County Rd. E
Dousman,  WI  53118
Applicant Contact ADRIENNE LENZ
Correspondent
Medela AG
W324 S3649 County Rd. E
Dousman,  WI  53118
Correspondent Contact ADRIENNE LENZ
Regulation Number878.4780
Classification Product Code
OMP  
Date Received12/14/2011
Decision Date 10/01/2012
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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