Clearance Summary
BOUNDARY SINGLE-USE GOWNS received FDA 510(k) clearance under submission number K834332, sponsored by Procter & Gamble Mfg. Co.. 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 1984-05-01.
- Submission: K834332
- Applicant / Sponsor: Procter & Gamble Mfg. Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1984-05-01
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.