Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)— 510(k) K203276
Substantially EquivalentBiocompatibles UK Ltd (Part of Boston Scientific Corporation
FDA 510(k) clearance K203276 for Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml), Substantially Equivalent on 2021-04-20. Applicant: Biocompatibles UK Ltd (Part of Boston Scientific Corporation.
Clearance details
- Applicant
- Biocompatibles UK Ltd (Part of Boston Scientific Corporation
- Product code
- Code NOY
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Farnham, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.