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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
3M Company
Bldg. 275-5W-06
st. paul,  MN  55144
Applicant Contact hilary b. hovde
3M Company
Bldg. 275-5W-06
st. paul,  MN  55144
Correspondent Contact hilary b. hovde
Classification Product Code
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