Clearance Summary
PACIFIC SURGICAL PATTIES received FDA 510(k) clearance under submission number K993019, sponsored by V. Mueller Neuro/Spine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2000-03-30.
- Submission: K993019
- Applicant / Sponsor: V. Mueller Neuro/Spine
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4700
- Decision date: 2000-03-30
Classification & Regulation
This clearance is catalogued under FDA product code HBA and 21 CFR 882.4700, within the Neurology review panel as a Class II device.