Clearance Summary
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES received FDA 510(k) clearance under submission number K050508, sponsored by Haywood Vocational Opportunities. 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 2005-04-27.
- Submission: K050508
- Applicant / Sponsor: Haywood Vocational Opportunities
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2005-04-27
Classification & Regulation
This clearance is catalogued under FDA product code KKX and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.