Clearance Summary
DERMALEX OR NATRAWOOL SKIN PRESSURE PROT received FDA 510(k) clearance under submission number K801195, sponsored by Stock Wild & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1980-06-09.
- Submission: K801195
- Applicant / Sponsor: Stock Wild & Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6450
- Decision date: 1980-06-09
Classification & Regulation
This clearance is catalogued under FDA product code FMP and 21 CFR 880.6450, within the General Hospital review panel as a Class I device.