Clearance Summary
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 received FDA 510(k) clearance under submission number K092167, sponsored by Kimberly-Clark 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 2009-11-02.
- Submission: K092167
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2009-11-02
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.