Clearance Summary
STERILIZATION PROCESS/OUTERWRAP received FDA 510(k) clearance under submission number K792633, sponsored by Procter & Gamble Mfg. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1980-01-11.
- Submission: K792633
- Applicant / Sponsor: Procter & Gamble Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1980-01-11
Classification & Regulation
This clearance is catalogued under FDA product code KET and 21 CFR 864.3010, within the Pathology review panel as a Class I device.