Clearance Summary
BLADDER NECK SUPPORT PROTHESIS FITTING KIT received FDA 510(k) clearance under submission number K933654, sponsored by Johnson & Johnson Medical, 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 1995-05-04.
- Submission: K933654
- Applicant / Sponsor: Johnson & Johnson Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3575
- Decision date: 1995-05-04
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.