Clearance Summary
JAIN SUTURE/VESIBAND ORGANIZER received FDA 510(k) clearance under submission number K905105, sponsored by Jain Surgical Equipment, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1991-01-31.
- Submission: K905105
- Applicant / Sponsor: Jain Surgical Equipment, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1991-01-31
Classification & Regulation
This clearance is catalogued under FDA product code MDM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.