Clearance Summary
SPLATTER SHIELD received FDA 510(k) clearance under submission number K915676, sponsored by Chathamborough Research Group, 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 1992-09-11.
- Submission: K915676
- Applicant / Sponsor: Chathamborough Research Group, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1992-09-11
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.