Clearance Summary
WEC-KLEEN, CATALOG N. 850-102 received FDA 510(k) clearance under submission number K861590, sponsored by Palmetto Chemical & Supply Co., 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 1986-06-17.
- Submission: K861590
- Applicant / Sponsor: Palmetto Chemical & Supply Co., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6150
- Decision date: 1986-06-17
Classification & Regulation
This clearance is catalogued under FDA product code FLG and 21 CFR 880.6150, within the General Hospital review panel as a Class I device.