Fusion Bx 2.0
Focal Healthcare Inc.
Focal Healthcare Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011853771 | 3011853771 | Focal Healthcare Inc. | 1 | N | 2026-01-01 | 10 Morrow Ave., Unit 101 Toronto Ontario CA M6R2J1 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 191680 | 1905215609 | K181290 | Fusion Bx 2.0 | LLZ | 2018-06-15 |
| 191680 | 2050144403 | K153166 | Fusion Bx | LLZ | 2016-01-25 |
| 191680 | 1051779863 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LLZ | 2 | 2018-06-15 |