Clearance Summary
HYDROGEL SKIN DRESSING received FDA 510(k) clearance under submission number K962352, sponsored by North American Sterilization & Packaging Co.. 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 1996-08-02.
- Submission: K962352
- Applicant / Sponsor: North American Sterilization & Packaging Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4022
- Decision date: 1996-08-02
Classification & Regulation
This clearance is catalogued under FDA product code NAE and 21 CFR 878.4022, within the General, Plastic Surgery review panel as a Class I device.