Clearance Summary
MAGNET PAD received FDA 510(k) clearance under submission number K896802, sponsored by Westmark, Sterile Packing Systems, Inc. (Sps). The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1989-12-27.
- Submission: K896802
- Applicant / Sponsor: Westmark, Sterile Packing Systems, Inc. (Sps)
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1989-12-27
Classification & Regulation
This clearance is catalogued under FDA product code LXG and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.