Clearance Summary
LEININGEO AORTIC PUNCH #310-395 & 397 received FDA 510(k) clearance under submission number K771625, sponsored by J. Jamner Surgical Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1977-09-12.
- Submission: K771625
- Applicant / Sponsor: J. Jamner Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1977-09-12
Classification & Regulation
This clearance is catalogued under FDA product code DWS and 21 CFR 870.4500, within the Cardiovascular review panel as a Class I device.