Clearance Summary
PERINEOMETER received FDA 510(k) clearance under submission number K960311, sponsored by Hollister, 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 1996-04-18.
- Submission: K960311
- Applicant / Sponsor: Hollister, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1425
- Decision date: 1996-04-18
Classification & Regulation
This clearance is catalogued under FDA product code HIR and 21 CFR 884.1425, within the Obstetrics/Gynecology review panel as a Class II device.