Clearance Summary
LIMB COVER received FDA 510(k) clearance under submission number K780905, sponsored by Hydro-Med Products, 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 1978-08-14.
- Submission: K780905
- Applicant / Sponsor: Hydro-Med Products, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 1978-08-14
Classification & Regulation
This clearance is catalogued under FDA product code IPM and 21 CFR 890.3025, within the Physical Medicine review panel as a Class I device.