Clearance Summary
WEDGE TIP, SMALL, MODEL #030-194 received FDA 510(k) clearance under submission number K770283, sponsored by Med Telectronics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1977-02-24.
- Submission: K770283
- Applicant / Sponsor: Med Telectronics , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 1977-02-24
Classification & Regulation
This clearance is catalogued under FDA product code DTB and 21 CFR 870.3680, within the Cardiovascular review panel as a Class III device.