Clearance Summary
CHESSON LABS LIQUID BANDAGE received FDA 510(k) clearance under submission number K083913, sponsored by Chesson Laboratory Associates, Inc.. 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 2009-07-31.
- Submission: K083913
- Applicant / Sponsor: Chesson Laboratory Associates, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 2009-07-31
Classification & Regulation
This clearance is catalogued under FDA product code KMF and 21 CFR 880.5090, within the General Hospital review panel as a Class I device.