Clearance Summary
ORTHO ALL-FLEX DIAPHRAGM received FDA 510(k) clearance under submission number K080040, sponsored by Johnson & Johnson Produtos Profissionais Ltda.. 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 2008-08-25.
- Submission: K080040
- Applicant / Sponsor: Johnson & Johnson Produtos Profissionais Ltda.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5350
- Decision date: 2008-08-25
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.