Clearance Summary
SAFETOUCH received FDA 510(k) clearance under submission number K014300, sponsored by James D Rusin MD, MBA. 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 2002-03-01.
- Submission: K014300
- Applicant / Sponsor: James D Rusin MD, MBA
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2990
- Decision date: 2002-03-01
Classification & Regulation
This clearance is catalogued under FDA product code NHM and 21 CFR 884.2990, within the Obstetrics/Gynecology review panel as a Class II device.