Clearance Summary
INGLAT-O-BALL received FDA 510(k) clearance under submission number K904774, sponsored by Milex Products, 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 1990-12-07.
- Submission: K904774
- Applicant / Sponsor: Milex Products, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3575
- Decision date: 1990-12-07
Classification & Regulation
This clearance is catalogued under FDA product code HHW and 21 CFR 884.3575, within the Obstetrics/Gynecology review panel as a Class II device.