Clearance Summary
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 received FDA 510(k) clearance under submission number K042527, sponsored by Medical Action Industries, 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 2004-11-08.
- Submission: K042527
- Applicant / Sponsor: Medical Action Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2004-11-08
Classification & Regulation
This clearance is catalogued under FDA product code HHT and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.