Clearance Summary
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS received FDA 510(k) clearance under submission number K063223, sponsored by CooperSurgical, 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 2008-01-23.
- Submission: K063223
- Applicant / Sponsor: CooperSurgical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5350
- Decision date: 2008-01-23
Classification & Regulation
This clearance is catalogued under FDA product code HDW and 21 CFR 884.5350, within the Obstetrics/Gynecology review panel as a Class II device.