Clearance Summary
MAXI & MINI SHIELDS received FDA 510(k) clearance under submission number K820960, sponsored by Dafoe & Dafoe, Inc.. 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 1982-05-14.
- Submission: K820960
- Applicant / Sponsor: Dafoe & Dafoe, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5435
- Decision date: 1982-05-14
Classification & Regulation
This clearance is catalogued under FDA product code HHD and 21 CFR 884.5435, within the Obstetrics/Gynecology review panel as a Class I device.