Clearance Summary
STOMAHESIVE PASTE PROTECTIVE SKIN BARR received FDA 510(k) clearance under submission number K803100, 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 1981-01-08.
- Submission: K803100
- 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: 1981-01-08
Classification & Regulation
This clearance is catalogued under FDA product code EZR and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.