510(k) K200835
K200835 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad". The FDA issued a decision of Substantially Equivalent on Sep 4, 2020. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. 3M Company has 334 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 4, 2020
- Date Received
- Mar 31, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)