Clearance Summary
STERILIZATION PROCESS/PLACENTA BASIN received FDA 510(k) clearance under submission number K792625, sponsored by Procter & Gamble Mfg. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1980-01-16.
- Submission: K792625
- Applicant / Sponsor: Procter & Gamble Mfg. Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6730
- Decision date: 1980-01-16
Classification & Regulation
This clearance is catalogued under FDA product code FNY and 21 CFR 880.6730, within the General Hospital review panel as a Class I device.