Embosphere Microspheres— 510(k) DEN160040
UnknownBiosphere Medical, S.A.
FDA 510(k) clearance DEN160040 for Embosphere Microspheres, Unknown on 2017-06-21. Applicant: Biosphere Medical, S.A.. Device class: 2.
Clearance details
- Applicant
- Biosphere Medical, S.A.
- Product code
- Code NOY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5550
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- 383 Rue De La Belle Etoile, FR
Recent devices under product code NOY
view all- K203276 — 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)
- K192684 — HydroPearl Microspheres
- K180102 — Embozene Color-Advanced Microspheres
More clearances from Biosphere Medical, S.A.
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