ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
Insung Medical Co., Ltd.
INSUNG MEDICAL CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013023209 | 3013023209 | INSUNG MEDICAL CO., LTD. | 1 | N | 2026-01-01 | 168, GIEOPDOSI-RO, JIJEONG-MYEON WONJU-SI Gangwon KR 26354 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 280627 | 1357609024 | K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | CBI | 2020-12-28 |
| 280627 | 1039082344 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| CBI | 1 | 2020-12-28 |