Clearance Summary
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE received FDA 510(k) clearance under submission number K040936, sponsored by Leda Co., Ltd.. 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 2004-05-03.
- Submission: K040936
- Applicant / Sponsor: Leda Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5075
- Decision date: 2004-05-03
Classification & Regulation
This clearance is catalogued under FDA product code FQM and 21 CFR 880.5075, within the General Hospital review panel as a Class I device.