Clearance Summary
EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 received FDA 510(k) clearance under submission number K972430, sponsored by Custom Services Intl., 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 1997-09-10.
- Submission: K972430
- Applicant / Sponsor: Custom Services Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5310
- Decision date: 1997-09-10
Classification & Regulation
This clearance is catalogued under FDA product code LTZ and 21 CFR 884.5310, within the Obstetrics/Gynecology review panel as a Class II device.