Clearance Summary
INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) received FDA 510(k) clearance under submission number K032631, sponsored by Lac Mac, 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 2004-02-05.
- Submission: K032631
- Applicant / Sponsor: Lac Mac, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2004-02-05
Classification & Regulation
This clearance is catalogued under FDA product code FYA and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.