Clearance Summary
SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY received FDA 510(k) clearance under submission number K802139, sponsored by Dyn-A-Med Products. 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 1980-10-31.
- Submission: K802139
- Applicant / Sponsor: Dyn-A-Med Products
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1980-10-31
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.