Clearance Summary
ALLDRESS MULTI LAYERED WOUND DRESSING received FDA 510(k) clearance under submission number K910857, sponsored by Scott Health Care. 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 1991-04-12.
- Submission: K910857
- Applicant / Sponsor: Scott Health Care
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4014
- Decision date: 1991-04-12
Classification & Regulation
This clearance is catalogued under FDA product code NAB and 21 CFR 878.4014, within the General, Plastic Surgery review panel as a Class I device.