Clearance Summary
DECALCIFYING SOLUTION II received FDA 510(k) clearance under submission number K881359, sponsored by Stephens Scientific. 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 1988-04-19.
- Submission: K881359
- Applicant / Sponsor: Stephens Scientific
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4730
- Decision date: 1988-04-19
Classification & Regulation
This clearance is catalogued under FDA product code KOX and 21 CFR 878.4730, within the General, Plastic Surgery review panel as a Class I device.