Clearance Summary
WORD BARTHOLIN GLAND CATHETER CODE: 1005 received FDA 510(k) clearance under submission number K880497, sponsored by Hoosier Specialties, 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 1988-03-24.
- Submission: K880497
- Applicant / Sponsor: Hoosier Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1988-03-24
Classification & Regulation
This clearance is catalogued under FDA product code KNA and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.