Clearance Summary
CIRCUMAURAL ADHESIVE REPLACEMENT received FDA 510(k) clearance under submission number K111555, sponsored by R & D Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-07-25.
- Submission: K111555
- Applicant / Sponsor: R & D Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 2011-07-25
Classification & Regulation
This clearance is catalogued under FDA product code GWJ and 21 CFR 882.1900, within the Neurology review panel as a Class II device.