Clearance Summary
ACTIVE-LIFE received FDA 510(k) clearance under submission number K780454, sponsored by E. R. Squibb & Sons, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1978-04-21.
- Submission: K780454
- Applicant / Sponsor: E. R. Squibb & Sons, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 1978-04-21
Classification & Regulation
This clearance is catalogued under FDA product code EXB and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.