Clearance Summary
Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac received FDA 510(k) clearance under submission number K212320, sponsored by 3M Healthcare Business Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-09-28.
- Submission: K212320
- Applicant / Sponsor: 3M Healthcare Business Group
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2021-09-28
Classification & Regulation
This clearance is catalogued under FDA product code OMP and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.