Clearance Summary
UNSTERILIZED LAPAROTOMY SPONGES (CHINA) received FDA 510(k) clearance under submission number K811632, sponsored by Robert I. Chien & Assoc., 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 1981-09-11.
- Submission: K811632
- Applicant / Sponsor: Robert I. Chien & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4450
- Decision date: 1981-09-11
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.