Clearance Summary
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP received FDA 510(k) clearance under submission number K993871, sponsored by Allegiance Healthcare Corp.. 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 2000-04-21.
- Submission: K993871
- Applicant / Sponsor: Allegiance Healthcare Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2000-04-21
Classification & Regulation
This clearance is catalogued under FDA product code FRG and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.