Clearance Summary
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT received FDA 510(k) clearance under submission number K844196, sponsored by Biological & Environmental Control Laboratories. 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 1984-12-04.
- Submission: K844196
- Applicant / Sponsor: Biological & Environmental Control Laboratories
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6060
- Decision date: 1984-12-04
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.