Clearance Summary
GOWN, ISOLATION, SURGICAL (FYC) received FDA 510(k) clearance under submission number K882281, sponsored by A Plus International, 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 1988-06-23.
- Submission: K882281
- Applicant / Sponsor: A Plus International, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1988-06-23
Classification & Regulation
This clearance is catalogued under FDA product code FYC and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.