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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K153571
Device Name Cavilon Advanced High Endurance Skin Protectant
Applicant
3M HEALTH CARE
3M CENTER, 2510 CONWAY AVE.,
BLDG 275-5W-06
ST.PAUL,  MN  55144
Applicant Contact MARIA RUIZ
Correspondent
3M HEALTH CARE
3M CENTER, 2510 CONWAY AVE.,
BLDG 275-5W-06
ST. PAUL,  MN  55144
Correspondent Contact MARIA RUIZ
Regulation Number880.5090
Classification Product Code
KMF  
Date Received12/15/2015
Decision Date 08/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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