Clearance Summary
SAV-A-LIMB received FDA 510(k) clearance under submission number K833872, sponsored by Sil-Med Corp.. 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 1984-02-04.
- Submission: K833872
- Applicant / Sponsor: Sil-Med Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6050
- Decision date: 1984-02-04
Classification & Regulation
This clearance is catalogued under FDA product code KYR and 21 CFR 880.6050, within the General Hospital review panel as a Class I device.