Clearance Summary
MALE INSERT SLIP received FDA 510(k) clearance under submission number K840482, sponsored by Beghin_Say Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1984-02-21.
- Submission: K840482
- Applicant / Sponsor: Beghin_Say Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5920
- Decision date: 1984-02-21
Classification & Regulation
This clearance is catalogued under FDA product code EYQ and 21 CFR 876.5920, within the Gastroenterology, Urology review panel as a Class I device.