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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Securement Wound Dressing For Reduction Of Infection
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
SEL  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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