Clearance Summary
LAITINEN'S TRIGEMINUS STEREOGUIDE received FDA 510(k) clearance under submission number K881132, sponsored by Sandstrom Trade & Technology, 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 1988-08-09.
- Submission: K881132
- Applicant / Sponsor: Sandstrom Trade & Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 1988-08-09
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.