The following data is part of a premarket notification filed by Enbio Group Ag with the FDA for Enbio S.
| Device ID | K210279 |
| 510k Number | K210279 |
| Device Name: | Enbio S |
| Classification | Sterilizer, Steam |
| Applicant | Enbio Group AG Eichengasse 3 Oensingen, CH Ch-4702 |
| Contact | Lukasz Rogowski |
| Correspondent | Lukasz Rogowski Enbio Group AG Eichengasse 3 Oensingen, CH Ch-4702 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-10-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENBIO S 97169643 not registered Live/Pending |
ENBIO TECHNOLOGY Sp. z o.o. 2021-12-13 |
![]() ENBIO S 97169643 not registered Live/Pending |
ENBIO GROUP AG 2021-12-13 |