Clearance Summary
MULTISURFACE ROLLER BOTTLE (M.S.R.B.) received FDA 510(k) clearance under submission number K880509, sponsored by Motil Plastics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1988-04-01.
- Submission: K880509
- Applicant / Sponsor: Motil Plastics , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2240
- Decision date: 1988-04-01
Classification & Regulation
This clearance is catalogued under FDA product code KJC and 21 CFR 864.2240, within the Hematology review panel as a Class I device.