Clearance Summary
PERIPRO PATCH received FDA 510(k) clearance under submission number K052416, sponsored by Hancock/Jaffe Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-10-25.
- Submission: K052416
- Applicant / Sponsor: Hancock/Jaffe Laboratories
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 2005-10-25
Classification & Regulation
This clearance is catalogued under FDA product code DXZ and 21 CFR 870.3470, within the Cardiovascular review panel as a Class II device.