Clearance Summary
BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR received FDA 510(k) clearance under submission number K992767, sponsored by Albert Browne , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2000-01-10.
- Submission: K992767
- Applicant / Sponsor: Albert Browne , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2000-01-10
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.