Clearance Summary
STERILE ORTHOPEDIC STOCKINETTE received FDA 510(k) clearance under submission number K780547, 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 1978-04-10.
- Submission: K780547
- Applicant / Sponsor: Alba-Waldensian, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 1978-04-10
Classification & Regulation
This clearance is catalogued under FDA product code ILG and 21 CFR 890.3475, within the Physical Medicine review panel as a Class I device.