Clearance Summary
MAXIMUM CONTROL GOWN received FDA 510(k) clearance under submission number K874318, sponsored by Ulti-Med Intl., 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 1987-12-02.
- Submission: K874318
- Applicant / Sponsor: Ulti-Med Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1987-12-02
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.