Clearance Summary
LOSEFF BALLOON TYPE SELF-RETENTION WOUND received FDA 510(k) clearance under submission number K801349, sponsored by Loseff Medical Designers, Ltd.. 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 1980-08-07.
- Submission: K801349
- Applicant / Sponsor: Loseff Medical Designers, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 1980-08-07
Classification & Regulation
This clearance is catalogued under FDA product code JCX and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.