Clearance Summary
COMPRESSION DEVICES, LIMB received FDA 510(k) clearance under submission number K781964, sponsored by Alba-Waldensian, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1978-12-12.
- Submission: K781964
- Applicant / Sponsor: Alba-Waldensian, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 1978-12-12
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.