Clearance Summary
MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET received FDA 510(k) clearance under submission number K873109, sponsored by Life-Tech Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1987-08-28.
- Submission: K873109
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1987-08-28
Classification & Regulation
This clearance is catalogued under FDA product code OJA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.