The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Tegaderm Chg Chlorhexidine Gluconate Gel Pad.
Device ID | K200835 |
510k Number | K200835 |
Device Name: | 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad |
Classification | Dressing, Wound, Drug |
Applicant | 3M Company Bldg. 275-5W-06 St. Paul, MN 55144 |
Contact | Hilary B. Hovde |
Correspondent | Hilary B. Hovde 3M Company Bldg. 275-5W-06 St. Paul, MN 55144 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2020-03-31 |
Decision Date | 2020-09-04 |