Clearance Summary
DR. HESSEL'S INSECT POISON REMOVER received FDA 510(k) clearance under submission number K844048, sponsored by Medie Group. 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 1985-01-23.
- Submission: K844048
- Applicant / Sponsor: Medie Group
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5740
- Decision date: 1985-01-23
Classification & Regulation
This clearance is catalogued under FDA product code KYP and 21 CFR 880.5740, within the General Hospital review panel as a Class I device.