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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 K180205
Device Name AVELLE Negative Pressure Wound Therapy System
Applicant
Convatec Limited
First Ave.
Deeside,  GB CH5 2NU
Applicant Contact Justin Lovelace
Correspondent
Convatec Limited
First Ave.
Deeside,  GB CH5 2NU
Correspondent Contact Justin Lovelace
Regulation Number878.4780
Classification Product Code
OMP  
Date Received01/24/2018
Decision Date 10/19/2018
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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