Clearance Summary
STERILE ESMARCH BANDAGE received FDA 510(k) clearance under submission number K881176, sponsored by Spectrum/Hydro-Med Products, Inc.. 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 1988-04-11.
- Submission: K881176
- Applicant / Sponsor: Spectrum/Hydro-Med Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5900
- Decision date: 1988-04-11
Classification & Regulation
This clearance is catalogued under FDA product code GAX and 21 CFR 878.5900, within the General, Plastic Surgery review panel as a Class I device.