Clearance Summary
LAPAROSCOPY DRAPE, BOUNDARY received FDA 510(k) clearance under submission number K772301, 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 1977-12-20.
- Submission: K772301
- Applicant / Sponsor: Procter & Gamble Mfg. Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1977-12-20
Classification & Regulation
This clearance is catalogued under FDA product code FZT and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.