Clearance Summary
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER received FDA 510(k) clearance under submission number K910282, sponsored by Graphic Controls Corp.. 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 1991-03-29.
- Submission: K910282
- Applicant / Sponsor: Graphic Controls Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2720
- Decision date: 1991-03-29
Classification & Regulation
This clearance is catalogued under FDA product code HFM and 21 CFR 884.2720, within the Obstetrics/Gynecology review panel as a Class II device.