Clearance Summary
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 received FDA 510(k) clearance under submission number K992079, sponsored by The Kendall Company, L.P.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-09-29.
- Submission: K992079
- Applicant / Sponsor: The Kendall Company, L.P.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 1999-09-29
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.