Clearance Summary
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 received FDA 510(k) clearance under submission number K060097, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-02-27.
- Submission: K060097
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4800
- Decision date: 2006-02-27
Classification & Regulation
This clearance is catalogued under FDA product code GZT and 21 CFR 882.4800, within the Neurology review panel as a Class II device.