Clearance Summary
GAUZE & LAB SPONGES STERILE & NON received FDA 510(k) clearance under submission number K842572, 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 1984-08-15.
- Submission: K842572
- Applicant / Sponsor: Ulti-Med Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4450
- Decision date: 1984-08-15
Classification & Regulation
This clearance is catalogued under FDA product code GDY and 21 CFR 878.4450, within the General, Plastic Surgery review panel as a Class I device.