Clearance Summary
STERILE TV CAMERA & CORD COVER received FDA 510(k) clearance under submission number K812405, sponsored by Hydro-Med Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1981-10-20.
- Submission: K812405
- Applicant / Sponsor: Hydro-Med Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 1981-10-20
Classification & Regulation
This clearance is catalogued under FDA product code KQM and 21 CFR 878.4160, within the General, Plastic Surgery review panel as a Class I device.