Clearance Summary
MODIFICATION OF: STERRAD BI TEST PACK received FDA 510(k) clearance under submission number K991675, sponsored by Advanced Sterilization Products. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1999-06-15.
- Submission: K991675
- Applicant / Sponsor: Advanced Sterilization Products
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 1999-06-15
Classification & Regulation
This clearance is catalogued under FDA product code FRC and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.