Clearance Summary
PELVIC EXAM TRAY received FDA 510(k) clearance under submission number K800874, sponsored by Pharmaseal Laboratories. 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 1980-05-08.
- Submission: K800874
- Applicant / Sponsor: Pharmaseal Laboratories
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5435
- Decision date: 1980-05-08
Classification & Regulation
This clearance is catalogued under FDA product code HHD and 21 CFR 884.5435, within the Obstetrics/Gynecology review panel as a Class I device.