Clearance Summary
I.V. ROLLER GUARD CLAMP received FDA 510(k) clearance under submission number K942446, sponsored by Plastic Manufacturing and Marketing 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 1995-02-17.
- Submission: K942446
- Applicant / Sponsor: Plastic Manufacturing and Marketing Group, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1995-02-17
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.