Clearance Summary
KIMGUARD SMART-FOLD* STERILIZATION WRAP received FDA 510(k) clearance under submission number K112300, sponsored by Kimberly-Clark Corp.. 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 2012-01-19.
- Submission: K112300
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2012-01-19
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.