Clearance Summary
ACCU PATH STERILE LABEL received FDA 510(k) clearance under submission number K904598, sponsored by Accu-Path. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1990-10-30.
- Submission: K904598
- Applicant / Sponsor: Accu-Path
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1990-10-30
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.