Clearance Summary
J105 JAMES SURGICAL SYSTEM I/A PACK received FDA 510(k) clearance under submission number K911932, sponsored by O.R. Specialties, 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 1991-08-26.
- Submission: K911932
- Applicant / Sponsor: O.R. Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4525
- Decision date: 1991-08-26
Classification & Regulation
This clearance is catalogued under FDA product code GZX and 21 CFR 882.4525, within the Neurology review panel as a Class I device.