Clearance Summary
FLUID SOAKERSHIELD received FDA 510(k) clearance under submission number K900643, sponsored by Infection Control Products, 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 1990-04-25.
- Submission: K900643
- Applicant / Sponsor: Infection Control Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6060
- Decision date: 1990-04-25
Classification & Regulation
This clearance is catalogued under FDA product code KME and 21 CFR 880.6060, within the General Hospital review panel as a Class I device.