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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 K200835
Device Name 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
Applicant
3M Company
Bldg.275-5w-06
St. Paul,  MN  55144
Applicant Contact Hilary B. Hovde
Correspondent
3M Company
Bldg.275-5w-06
St. Paul,  MN  55144
Correspondent Contact Hilary B. Hovde
Classification Product Code
FRO  
Date Received03/31/2020
Decision Date 09/04/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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