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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(k) Number K153410
Device Name 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
Applicant
3M COMPANY
3M CENTER, 2510 CONWAY AVE, BLDG 275-5W-06
ST.PAUL,  MN  55144
Applicant Contact Melissa Forth
Correspondent
3M COMPANY
3M CENTER, 2510 CONWAY AVE, BLDG 275-5W-06
ST.PAUL,  MN  55144
Correspondent Contact Melissa Forth
Classification Product Code
FRO  
Date Received11/25/2015
Decision Date 05/15/2017
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01189682
Reviewed by Third Party No
Combination Product Yes
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