Clearance Summary
PETITES BETWEEN-PERIOD PROTECTORS received FDA 510(k) clearance under submission number K771547, sponsored by 3M Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1977-09-20.
- Submission: K771547
- Applicant / Sponsor: 3M Company
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5425
- Decision date: 1977-09-20
Classification & Regulation
This clearance is catalogued under FDA product code HHL and 21 CFR 884.5425, within the Obstetrics/Gynecology review panel as a Class II device.